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Business Wire
a day ago
- Health
- Business Wire
Genentech's Lunsumio and Polivy Combination Significantly Prolongs Remission for People With Relapsed or Refractory Large B-cell Lymphoma
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), presented today results from the Phase III SUNMO [ NCT05171647 ] study showing Lunsumio ® (mosunetuzumab-axgb) administered subcutaneously in combination with Polivy ® (polatuzumab vedotin-piiq) demonstrated a clinically meaningful and statistically significant improvement in its primary endpoints of progression-free survival (PFS) and objective response rate (ORR) compared to Rituxan ® (rituximab), gemcitabine and oxaliplatin (R-GemOx), in people with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) who are not eligible for transplant. Primary analysis data were featured at the 18 th International Conference on Malignant Lymphoma as a late-breaking oral presentation. Results from the SUNMO study will be submitted to global health authorities, including the U.S. Food and Drug Administration (FDA). The National Comprehensive Cancer Network ® (NCCN ®) has recently added Lunsumio and Polivy to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®) as a category 2A recommendation for the treatment of people with second-line (2L) diffuse large B-cell lymphoma (DLBCL) who are not intended to proceed to transplant. † 'Lunsumio and Polivy represent the first combination of a bispecific antibody and antibody-drug conjugate, which could avoid chemotherapy and potentially provide an alternative option for some patients with relapsed or refractory LBCL,' said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. 'We are also encouraged by the favorable safety profile and potential for outpatient use of this regimen, which may suit diverse patient and healthcare system needs.' At a median follow-up of 23.2 months, the Lunsumio and Polivy combination demonstrated a 59% reduction in risk of disease progression or death compared to R-GemOx (hazard ratio [HR] 0.41, 95% confidence interval [CI]: 0.28–0.61; p<0.0001). Median PFS was three times longer with Lunsumio and Polivy at 11.5 months (95% CI: 5.6-17.6), compared to 3.8 months for R-GemOx (95% CI: 2.9-4.1) and 12-month PFS was more than doubled at 48.5% (95% CI: 39.6-57.4) vs.17.8% (95% CI: 5.4-30.3), respectively. This PFS benefit was consistent across subgroups, including in high-risk patients with primary refractory disease (HR 0.46, 95% CI: 0.29–0.72). At the interim analysis, overall survival (OS) data were not yet mature. OS numerically favored the Lunsumio and Polivy combination with a median of 18.7 months (95% CI: 14.1–not evaluable [NE]) compared to 13.6 months for R-GemOx (95% CI: 9.9–NE; HR 0.80; 95% CI: 0.54 - 1.20). 'There remains a clear need for effective and well-tolerated treatments for people with this difficult-to-treat disease,' said Jason Westin, professor of lymphoma and director of lymphoma clinical research, The University of Texas, MD Anderson Cancer Center. 'If approved, this off-the-shelf treatment combination of mosunetuzumab-axgb and polatuzumab vedotin-piiq could be administered over a fixed period of time, without mandatory hospitalization or traditional chemotherapy, which could provide a meaningful option for patients with relapsed or refractory LBCL.' In the Lunsumio and Polivy arm, 30% more patients achieved an objective response (70.3%, 95% CI: 61.9-77.8) compared to R-GemOx (40.0%; 95% CI: 28.5-52.4), and the complete response rate was doubled at 51.4% (95% CI: 42.8-60.0) versus 24.3% (95% CI: 14.8-36.0). Nearly 75% of patients with a complete response were still in remission after one year (72.6%; 95% CI: 61.4-83.8) compared to 44.1% for R-GemOx (95% CI: 13.2-74.9). The safety profile of the Lunsumio and Polivy combination was consistent with the known profiles of the individual study medicines, potentially allowing use across outpatient and community settings. The incidence of cytokine release syndrome (CRS) events in the Lunsumio plus Polivy arm was low, occurring in one in four patients, with less than 5% of patients experiencing Grade 2 or 3 CRS events. No immune effector cell-associated neurotoxicity syndrome events were reported. Rates of Grade 3–4 (58.5% vs. 57.8%) and Grade 5 (5.2% vs. 6.3%) adverse events (AEs) were similar between the combination and R-GemOx, with fewer AEs leading to treatment discontinuation in the Lunsumio and Polivy arm (2.2% vs. 4.7%). High-dose chemotherapy followed by stem-cell transplant has traditionally been the standard 2L treatment for people with R/R LBCL. While 2L therapies have advanced, DLBCL can progress rapidly and many people are not candidates for, cannot tolerate, or do not have access to latest therapies. There is an urgent need for treatments that are rapidly available upon a diagnosis of relapse, that can manage the disease and improve long-term outcomes. Genentech's lymphoma portfolio is one of the broadest in the industry, providing a unique and much-needed opportunity to combine regimens with different and complementary mechanisms of action. We are exploring our CD20xCD3 bispecifics, Lunsumio and Columvi ® (glofitamab-gxbm), alongside Polivy to move one step closer towards our goal of improving the lives of as many patients with lymphomas as possible. This includes the Phase III STARGLO study [ NCT04408638 ] evaluating the efficacy and safety of Columvi in combination with GemOx versus R-GemOx alone in patients with R/R DLBCL who have received at least one prior line of therapy and who are not candidates for autologous stem cell transplant, or who have received two or more prior lines of therapy. Lunsumio is already approved for people with R/R follicular lymphoma after two or more lines of therapy in more than 60 countries worldwide. Polivy in combination with R-CHP is approved for people with previously untreated diffuse large B-cell lymphoma (DLBCL) in more than 100 countries worldwide and in combination with bendamustine and Rituxan for R/R DLBCL in more than 90 countries worldwide. †NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way About the SUNMO study The SUNMO [ NCT05171647 ] study is an international, multi-center, randomized Phase III trial evaluating the efficacy and safety of subcutaneously administered Lunsmio ® (mosunetuzumab-axgb) in combination with intravenous Polivy ® (polatuzumab vedotin-piiq) compared to Rituxan ® (rituximab), gemcitabine and oxaliplatin (R-GemOx), in people with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) who are not eligible for autologous stem cell transplant. Outcome measures include progression-free survival and objective response rate (dual primary endpoints), overall survival, duration of objective response, complete response rate, duration of complete response, safety and tolerability, and patient-reported outcomes. About Lunsumio ® (mosunetuzumab-axgb) Lunsumio is a first-in-class CD20xCD3 T-cell-engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual-targeting activates and redirects a patient's existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells. A robust clinical development program for Lunsumio is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin lymphomas, including follicular lymphoma, diffuse large B-cell lymphoma, and other indications. About Polivy ® (polatuzumab vedotin-piiq) Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed in the majority of B cells, an immune cell impacted in some types of non-Hodgkin lymphoma (NHL), making it a promising target for the development of new therapies. Polivy binds to cancer cells such as those expressing CD79b and destroys these B cells through the delivery of an anti-cancer agent, which is thought to minimize the effects on normal cells. Polivy is being developed by Genentech using Pfizer ADC technology and is currently being investigated for the treatment of several types of NHL. About large B-cell lymphoma (LBCL) Large B-cell lymphomas (LBCL), composed predominantly of diffuse large B-cell lymphoma (DLBCL), are the most common type of non-Hodgkin lymphoma (NHL) that affect B-cell lymphocytes, a type of white blood cells. DLBCL is the most common form of aggressive NHL and makes up about 80% of LBCLs. While it can arise in lymph nodes, it can also occur in organs outside of the lymphatic system. Approximately 160,000 people worldwide are diagnosed with DLBCL each year, with comparable incidence rates across regions. Medical practices, including pathological classification, diagnosis, staging, initial treatment and relapse management, are similarly approached worldwide. While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short. Improving treatments earlier in the course of the disease and providing much needed alternative options could help to improve long-term outcomes. Lunsumio U.S. Indication Lunsumio (mosunetuzumab-axgb) is a prescription medicine used to treat adults with follicular lymphoma whose cancer has come back or did not respond to previous treatment, and who have already received two or more treatments for their cancer. It is not known if Lunsumio is safe and effective in children. The conditional approval of Lunsumio is based on response rate. There are ongoing studies to establish how well the drug works. What is the most important information I should know about Lunsumio? Lunsumio may cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with Lunsumio and can also be severe or life-threatening. Get medical help right away if you develop any signs or symptoms of CRS at any time, including: fever of 100.4°F (38°C) or higher chills low blood pressure fast or irregular heartbeat tiredness or weakness difficulty breathing headache confusion feeling anxious dizziness or light-headedness nausea vomiting Due to the risk of CRS, you will receive Lunsumio on a 'step-up dosing schedule.' The step-up dosing schedule is when you receive smaller 'step-up' doses of Lunsumio on Day 1 and Day 8 of your first cycle of treatment You will receive a higher dose of Lunsumio on Day 15 of your first cycle of treatment If your dose of Lunsumio is delayed for any reason, you may need to repeat the step-up dosing schedule Before each dose in Cycle 1 and Cycle 2, you will receive medicines to help reduce your risk of CRS Your healthcare provider will check you for CRS during treatment with Lunsumio and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment with Lunsumio, if you have severe side effects. What are the possible side effects of Lunsumio? Lunsumio may cause serious side effects, including: neurologic problems. Lunsumio can cause serious and life-threatening neurological problems. Your healthcare provider will check you for neurologic problems during treatment with Lunsumio. Your healthcare provider may also refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems during or after treatment with Lunsumio, including: headache numbness and tingling of the arms, legs, hands, or feet dizziness confusion and disorientation difficulty paying attention or understanding things forgetting things or forgetting who or where you are trouble speaking, reading, or writing sleepiness or trouble sleeping tremors loss of consciousness seizures muscle problems or muscle weakness loss of balance or trouble walking tiredness serious infections. Lunsumio can cause serious infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment. Tell your healthcare provider right away if you develop any signs or symptoms of infection during treatment with Lunsumio, including: fever of 100.4° F (38° C) or higher cough chest pain tiredness shortness of breath painful rash sore throat pain during urination feeling weak or generally unwell hemophagocytic lymphohistiocytosis (HLH). Lunsumio can cause overactivity of the immune system, a condition called hemophagocytic lymphohistiocytosis. HLH can be life-threatening and has led to death in people treated with Lunsumio. Your health care provider will check you for HLH especially if your CRS lasts longer than expected. Signs and symptoms of HLH include: fever enlarged spleen easy bruising low blood cell counts liver problems low blood cell counts. Low blood cell counts are common during treatment with Lunsumio and can also be serious or severe. Your healthcare provider will check your blood cell counts during treatment with Lunsumio. Lunsumio can cause the following low blood cell counts: low white blood cell counts (neutropenia). Low white blood cells can increase your risk for infection low red blood cell counts (anemia). Low red blood cells can cause tiredness and shortness of breath low platelet counts (thrombocytopenia). Low platelet counts can cause bruising or bleeding problems growth in your tumor or worsening of tumor related problems (tumor flare). Lunsumio can cause serious or severe worsening of your tumor. Tell your healthcare provider if you develop any of these signs or symptoms of tumor flare during your treatment with Lunsumio: chest pain cough trouble breathing tender or swollen lymph nodes pain or swelling at the site of the tumor Your healthcare provider may temporarily stop or permanently stop treatment with Lunsumio if you develop severe side effects. The most common side effects of Lunsumio include: tiredness, rash, fever, and headache. The most common severe abnormal blood test results with Lunsumio include: decreased phosphate, increased glucose, and increased uric acid levels. Before receiving Lunsumio, tell your healthcare provider about all of your medical conditions, including if you: have ever had an infusion reaction after receiving Lunsumio have an infection, or have had an infection in the past which lasted a long time or keeps coming back have or have had Epstein-Barr Virus are pregnant or plan to become pregnant. Lunsumio may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Lunsumio Females who are able to become pregnant: your healthcare provider should do a pregnancy test before you start treatment with Lunsumio you should use an effective method of birth control (contraception) during your treatment and for 3 months after the last dose of Lunsumio are breastfeeding or plan to breastfeed. It is not known if Lunsumio passes into your breast milk. Do not breastfeed during treatment and for 3 months after the last dose of Lunsumio Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What should I avoid while receiving Lunsumio? Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of CRS or neurologic problems. These are not all the possible side effects of Lunsumio. Talk to your healthcare provider for more information about the benefits and risks of Lunsumio. You may report side effects to the FDA at (800) FDA-1088 or You may also report side effects to Genentech at (888) 835-2555. Please see Important Safety Information, including Serious Side Effects, as well as the Lunsumio full Prescribing Information and Medication Guide or visit Polivy U.S. Indication Polivy is a prescription medicine used with other medicines (a rituximab product, cyclophosphamide, doxorubicin, and prednisone) as a first treatment for adults who have moderate to high risk diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL). Polivy is a prescription medicine used with other medicines, bendamustine and a rituximab product, to treat DLBCL in adults who have progressed after at least 2 prior therapies. Important Safety Information Possible serious side effects Everyone reacts differently to Polivy therapy, so it's important to know what the side effects are. Some people who have been treated with Polivy have experienced serious to fatal side effects. Your doctor may stop or adjust your treatment if any serious side effects occur. Be sure to contact your healthcare team if there are any signs of these side effects. Nerve problems in your arms and legs: This may happen as early as after your first dose and may worsen with every dose. Your doctor will monitor for signs and symptoms, such as changes in your sense of touch, numbness or tingling in your hands or feet, nerve pain, burning sensation, any muscle weakness, or changes to your walking pattern Infusion-related reactions: You may experience fever, chills, rash, breathing problems, low blood pressure, or hives within 24 hours of your infusion Low blood cell counts: Treatment with Polivy can cause severe low blood cell counts. Your doctor will monitor your blood counts throughout treatment with Polivy Infections: If you have a fever of 100.4°F (38°C) or higher, chills, cough, or pain during urination, contact your healthcare team. Your doctor may also give you medication before giving you Polivy, which may prevent some infections Rare and serious brain infections: Your doctor will monitor closely for signs and symptoms of these types of infections. Contact your doctor if you experience confusion, dizziness or loss of balance, trouble talking or walking, or vision changes Tumor lysis syndrome: Caused by the fast breakdown of cancer cells. Signs include nausea, vomiting, diarrhea, and lack of energy Potential harm to liver: Some signs include tiredness, weight loss, pain in the abdomen, dark urine, and yellowing of your skin or the white part of your eyes. You may be at higher risk if you already had liver problems or you are taking other medication Side effects seen most often The most common side effects during treatment were Nerve problems in arms and legs Nausea Tiredness or lack of energy Diarrhea Constipation Hair loss Redness and sores of the lining of the mouth, lips, throat, and digestive tract Polivy may lower your red or white blood cell counts and increase uric acid levels. Polivy may not be for everyone. Talk to your doctor if you are Pregnant or think you are pregnant: Data have shown that Polivy may harm your unborn baby Planning to become pregnant: Women should avoid getting pregnant while taking Polivy. Women should use effective contraception during treatment and for 3 months after their last Polivy treatment. Men taking Polivy should use effective contraception during treatment and for 5 months after their last Polivy treatment Breastfeeding: Women should not breastfeed while taking Polivy and for 2 months after the last dose These may not be all the side effects. Talk to your healthcare provider for more information about the benefits and risks of Polivy treatment. You may report side effects to the FDA at (800) FDA-1088 or You may also report side effects to Genentech at (888) 835-2555. Please see the full Prescribing Information and visit for additional Important Safety Information. About Columvi® (glofitamab-gxbm) Columvi is a CD20xCD3 T-cell engaging bispecific antibody designed to target CD3 on the surface of T cells and CD20 on the surface of B cells. Columvi was designed with a novel 2:1 structural format. This T-cell engaging bispecific antibody is engineered to have one region that binds to CD3, a protein on T cells, a type of immune cell, and two regions that bind to CD20, a protein on B cells, which can be healthy or malignant. This dual-targeting brings the T cell in close proximity to the B cell, activating the release of cancer cell-killing proteins from the T cell. Columvi is part of Genentech's broad and industry-leading CD20xCD3 T-cell-engaging bispecific antibody clinical development program that also includes Lunsumio® (mosunetuzumab-axgb), which aims to provide tailored treatment options that suit the diverse needs, preferences, and experiences of people with blood cancers and healthcare systems. Genentech is investigating Columvi as a monotherapy and in combination with other medicines for the treatment of diffuse large B-cell lymphoma and mantle cell lymphoma. Columvi U.S. Indication Columvi (glofitamab-gxbm) is a prescription medicine to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma (LBCL) that has come back (relapsed) or that did not respond to previous treatment (refractory), and who have received 2 or more prior treatments for their cancer. It is not known if Columvi is safe and effective in children. The conditional approval of Columvi is based on response rate and durability of response. There are ongoing studies to establish how well the drug works. What is the most important information I should know about Columvi? Columvi can cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with Columvi, and can also be serious and lead to death. Call your healthcare provider or get emergency medical help right away if you develop any signs or symptoms of CRS, including: fever of 100.4°F (38°C) or higher chills or shaking fast or irregular heartbeat dizziness or light-headedness trouble breathing shortness of breath Due to the risk of CRS, you will receive Columvi on a 'step-up dosing schedule'. A single dose of a medicine called obinutuzumab will be given to you on the first day of your first treatment cycle (Day 1 of Cycle 1). You will start the Columvi step-up dosing schedule a week after the obinutuzumab dose. The step-up dosing schedule is when you receive smaller 'step-up' doses of Columvi on Day 8 and Day 15 of Cycle 1. This is to help reduce your risk of CRS. You should be hospitalized during your infusion and for 24 hours after receiving the first step-up dose on Day 8. You should be hospitalized during your infusion and for 24 hours after receiving the second step-up dose on Day 15 if you experienced CRS during the first step-up dose. You will receive your first full dose of Columvi a week after the second step-up dose (this will be Day 1 of Cycle 2). If your dose of Columvi is delayed for any reason, you may need to repeat the 'step-up dosing schedule'. If you had more than mild CRS with your previous dose of Columvi, you should be hospitalized during and for 24 hours after receiving your next dose of Columvi. Before each dose of Columvi, you will receive medicines to help reduce your risk of CRS and infusion-related reactions. Your healthcare provider will monitor you for CRS during treatment with Columvi and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment with Columvi if you have severe side effects. Carry the Columvi Patient Wallet Card with you at all times and show it to all of your healthcare providers. The Columvi Patient Wallet Card lists the signs and symptoms of CRS you should get emergency medical help for right away. What are the possible side effects of Columvi? Columvi may cause serious side effects, including: Cytokine Release Syndrome. Neurologic problems. Columvi can cause serious neurologic problems that may lead to death. Your healthcare provider will monitor you for neurologic problems during treatment with Columvi. Your healthcare provider may also refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems, including: headache confusion and disorientation difficulty paying attention or understanding things trouble speaking sleepiness memory problems numbness, tingling, or weakness of the hands or feet dizziness shaking (tremors) Serious Infections. Columvi can cause serious infections that may lead to death. Your healthcare provider will monitor you for signs and symptoms of infection and treat you as needed. Tell your healthcare provider right away if you develop any signs of an infection, including: fever, chills, weakness, cough, shortness of breath, or sore throat. Growth in your tumor or worsening of tumor related problems (tumor flare). Tell your healthcare provider if you get any of these signs or symptoms of tumor flare: tender or swollen lymph nodes pain or swelling at the site of the tumor chest pain cough trouble breathing The most common side effects of Columvi include: CRS, muscle and bone pain, rash, and tiredness. The most common severe abnormal lab test results with Columvi include: decreased white blood cells, decreased phosphate (an electrolyte), increased uric acid levels, and decreased fibrinogen (a protein that helps with blood clotting). Your healthcare provider may temporarily stop or completely stop treatment with Columvi if you develop certain side effects. Before receiving Columvi, tell your healthcare provider about all of your medical conditions, including if you: have an infection have kidney problems are pregnant or plan to become pregnant. Columvi may harm your unborn baby Females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start treatment with Columvi. You should use effective birth control (contraception) during treatment and for 1 month after your last dose of Columvi. Talk to your healthcare provider about what birth control method is right for you during this time. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Columvi. are breastfeeding or plan to breastfeed. Columvi may pass into your breast milk. Do not breastfeed during treatment and for 1 month after your last dose of Columvi. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What should I avoid while receiving Columvi? Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, shaking (tremors), sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of neurologic problems. These are not all the possible side effects of Columvi. Talk to your health care provider for more information about the benefits and risks of Columvi. You may report side effects to the FDA at (800) FDA-1088 or You may also report side effects to Genentech at (888) 835-2555. Please see Important Safety Information, including Serious Side Effects, as well as the Columvi full Prescribing Information and Medication Guide or visit About Genentech in hematology For more than 20 years, Genentech has been developing medicines with the goal to redefine treatment in hematology. Today, we're investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. For more information visit About Genentech Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Genentech Group, has headquarters in South San Francisco, California. For additional information about the company, please visit
Politico
4 days ago
- Business
- Politico
BIO chair: U.S. has a ‘crisis' on drug costs
Driving The Day NEW BIO CHAIR'S POLICY TAKE — The biotech industry faces a mix of longstanding and novel political challenges amid President Donald Trump's second term. One of its chief lobbying arms is gearing up to take them on. Ahead of the Biotechnology Innovation Organization's annual convention this week in Boston, Genentech's Fritz Bittenbender — who was elected Monday as the group's board chair — chatted with Lauren about BIO's priority issues, distrust in science and medical institutions and its approach to geopolitical engagement. Pros can read the full Q&A, but here are some highlights and outtakes: An 'existential policy crisis': Bittenbender used the term to refer to debates around 'intellectual property, how do you pay for medicines, what kind of investments are we going to make at early-stage research' — all of which bring to mind Trump administration priorities like the most-favored-nation approach to bringing down drug prices and limiting National Institutes of Health spending on indirect costs in university research. 'We have a lot of sound-bite policy happening right now, and [most-favored-nation is] a great example of that,' he said, adding that the U.S. health system works much differently from those in allied European countries, often held up as examples of cheaper markets. How industry can combat distrust in science: Biotechs need to do a better job of communicating the benefits they bring to patients, and they need policymakers' help, Bittenbender said. 'Working with policymakers, and … bringing as much transparency to our industry as we possibly can — using real-world data and digital analytics more effectively to understand postmarketing studies of products on the market and being transparent about that,' he said. Federal job cuts: Regulatory uncertainty is an 'existential threat' to the industry amid the massive downsizing and restructuring of the Department of Health and Human Services, Bittenbender said. 'If it's going to take 10 or 15 years to bring a product to the market and $1 [billion] to $2 billion to do that, that's a significant investment over a long-term period. And for investors to want to do that, they have to know that there's a certain regulatory environment,' he said. 'They have to know that regulatory timelines are going to be met or exceeded.' The tariff threat: 'Our industry is a national security imperative for the country, and that means having essential medicines that patients really need manufactured here,' Bittenbender said. 'Hopefully, we won't see tariffs on the pharmaceutical industry, and we work in other ways to get manufacturing into the United States and to ensure that essential medicines that we need in times of emergency or pandemic are sourced from a place that we trust and that we know we can get them,' he added. IT'S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. NPR reports on how music therapy can help cancer patients manage their stress and symptoms. Send your tips to David Lim (dlim@ @davidalim or davidalim.49 on Signal) and Lauren Gardner (lgardner@ @Gardner_LM or gardnerlm.01 on Signal). Eye on the FDA SECOND DMD DRUG DEATH — A second patient with Duchenne muscular dystrophy has died after taking Sarepta Therapeutics' Elevidys gene therapy, the company said, prompting a reevaluation of the drug's treatment protocol. The death occurred in a 15-year-old nonambulatory individual enrolled in the company's randomized, placebo-controlled trial intended to confirm the drug's benefit in patients who can't walk under the FDA's accelerated approval pathway. A company official said the latest death shares 'some similarities to the previous' death of a teenage boy earlier this year; both fatalities were due to acute liver failure, a known side effect of the viral vector gene therapy used in Elevidys. Sarepta said the signal has emerged only in patients who can't walk, which they consider a surrogate for disease progression. Sarepta President and CEO Douglas Ingram said the company wants to meet with the FDA 'as rapidly as possible' to establish a new immunosuppressive regimen for nonambulatory patients. Until that's implemented, the company has paused drug shipments for that population, as well as dosing for its clinical trial, it said. Response: HHS spokesperson Emily Hilliard said the FDA is treating the death 'with the highest level of concern' and 'will take all appropriate regulatory actions to protect patients during our review of gene therapy products.' The FDA is reviewing a cell therapy candidate from Capricor Therapeutics to treat DMD. The target date for a decision is Aug. 31. PDUFA PROBLEMS? KalVista Pharmaceuticals raised some eyebrows late last week after announcing that the FDA had disclosed it would miss its Tuesday PDUFA target for the drug sebetralstat, which is used as therapy for hereditary angioedema, 'due to heavy workload and limited resources.' The rare disorder causes episodes of swelling in various parts of the body and can sometimes be fatal. FDA Commissioner Marty Makary has repeatedly said medical product reviews would continue apace despite thousands of job cuts at the agency, and reviewers were not among the terminated workers. But employees charged with supporting review staff by booking travel and securing supplies were impacted, and drug companies remain concerned about attrition in the remaining workforce. HHS did not comment. In Congress EXPANDED ORPHAN EXEMPTION OUT — The Senate Finance Committee's reconciliation bill strips an effort by the House to expand a Medicare drug price negotiations exemption for orphan drugs to include medicines that treat multiple rare diseases or conditions. The Congressional Budget Office estimated the policy in the House bill would cost the federal government nearly $5 billion over 10 years, a figure groups like AARP and Patients For Affordable Drugs Now used to urge senators to keep the measure out of the Senate bill. But pharmaceutical companies argue the provision would incentivize additional investment in rare-disease drug development as the IRA exemption currently applies to orphan drugs that treat a single rare disease. SANDERS WANTS ACIP INVESTIGATION — Senate HELP ranking member Bernie Sanders (I-Vt.) wants his counterpart to open a bipartisan investigation into the removal of 17 members of the CDC's outside vaccine committee. In his letter to Sen. Bill Cassidy (R-La.), chair of the Health, Education, Labor and Pensions Committee, Sanders asked for 'serious oversight' of HHS Secretary Robert F. Kennedy Jr.'s actions regarding the Advisory Committee for Immunization Practices. 'Secretary Kennedy's reckless decision to fire these non-partisan scientific experts and replace them with ideologues with limited expertise and a history of undermining vaccines will not only endanger the lives of Americans of all ages, it directly contradicts a commitment he made to you before he was confirmed that he would not make any significant changes to this important Committee,' Sanders wrote to Cassidy. A spokesperson for Cassidy did not immediately respond to a request for comment. In the courts PURDUE SETTLEMENT 2.0 — All 50 states and several U.S. territories have agreed to sign onto a $7.4 billion settlement with Purdue Pharma and its principal owners, the Sackler family, that will resolve state and local government claims. 'The local government sign-on and voting solicitation process for this settlement moving forward will be contingent on bankruptcy court approval,' California Attorney General Rob Bonta's office said in a news release. 'A hearing is scheduled on that matter in the coming days.' The settlement ends the Sackler family's control of Purdue and prevents them from selling opioids in the country. Document Drawer The FDA's Psychopharmacologic Drugs Advisory Committee will meet on July 18 to discuss Otsuka Pharmaceutical's supplemental new drug application to approve Rexulti to treat adults with post-traumatic stress disorder in combination with sertraline. The FDA published final guidance outlining recommendations for generic drugmakers on how to submit a pre-submission facility correspondence that can be used to help the agency begin site assessments in advance of submitting an abbreviated new drug application. WHAT WE'RE READING The 17 dismissed members of the CDC's vaccine advisory panel published an op-ed in JAMA, saying their abrupt dismissal last week 'undermines the committee's capacity to operate effectively and efficiently, aside from raising questions about competence.' HHS awarded an Arizona law firm $150,000 for its expertise on the Vaccine Injury Compensation Program, NOTUS' Margaret Manto reports, suggesting it's considering policy changes to the 40-year-old system.
Yahoo
5 days ago
- Business
- Yahoo
Genentech Provides Update on Phase III Verona Study
SOUTH SAN FRANCISCO, Calif., June 16, 2025--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and AbbVie announced today the outcome from the Phase III VERONA study (NCT04401748) investigating Venclexta® (venetoclax) plus azacitidine for patients with previously untreated higher-risk myelodysplastic syndromes (MDS). The study did not meet the primary endpoint of overall survival at the final analysis. The safety profile of the Venclexta combination was consistent with the known risk of the individual study medicines and no unexpected safety signals were observed. Full data will be presented at an upcoming medical meeting in 2025. VERONA is a global, AbbVie-led, Phase III, multicenter, randomized, double-blind study evaluating Venclexta in combination with azacitidine compared to placebo plus azacitidine in treatment-naïve patients with higher-risk MDS. The study includes approximately 500 patients across 220 sites globally who were randomly assigned to either Venclexta plus azacitidine or placebo plus azacitidine. Patients who received Venclexta in combination with azacitidine through participation in the MDS clinical trials will be informed by their treating physician. The results of the VERONA study have no impact on the approved indications for Venclexta or any ongoing studies. About Venclexta® (venetoclax) Venclexta is a first-in-class targeted medicine designed to bind selectively and inhibit the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers and other tumors, BCL-2 builds up and prevents cancer cells from dying or self-destructing, a process called apoptosis. Venclexta blocks the BCL-2 protein and works to help restore the process of apoptosis. Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the United States and commercialized by AbbVie outside of the United States. Together, the companies are committed to research with Venclexta, which is currently being studied in clinical trials across several types of blood cancers. Venclexta® (venetoclax) U.S. Indication Venclexta is a prescription medicine used: to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who: are 75 years of age or older, or have other medical conditions that prevent the use of standard chemotherapy. It is not known if Venclexta is safe and effective in children. Important Safety Information What is the most important information patients should know about Venclexta? Venclexta can cause serious side effects, including: Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. The patient's doctor will do tests to check their risk of getting TLS before they start taking Venclexta. The patient will receive other medicines before starting and during treatment with Venclexta to help reduce the risk of TLS. The patient may also need to receive intravenous (IV) fluids into their vein. The patient's doctor will do blood tests to check for TLS when the patient first starts treatment and during treatment with Venclexta. It is important for patients to keep appointments for blood tests. Patients should tell their doctor right away if they have any symptoms of TLS during treatment with Venclexta, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain. Patients should drink plenty of water during treatment with Venclexta to help reduce the risk of getting TLS. Patients should drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before the first dose on the day of the first dose of Venclexta, and each time a dose is increased. The patient's doctor may delay, decrease the dose, or stop treatment with Venclexta if the patient has side effects. When restarting Venclexta after stopping for 1 week or longer, the patient's doctor may again check for the risk of TLS and change the patient's dose. What patients should not take Venclexta? Certain medicines must not be taken when the patient first starts taking Venclexta and while the dose is being slowly increased because of the risk of increased TLS. Patients should tell their doctor about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Venclexta and other medicines may affect each other causing serious side effects. Patients must not start new medicines during treatment with Venclexta without first talking with their doctor. Before taking Venclexta, patients must tell their doctor about all of their medical conditions, including if they: Have kidney or liver problems. Have problems with body salts or electrolytes, such as potassium, phosphorus, or calcium. Have a history of high uric acid levels in the blood or gout. Are scheduled to receive a vaccine. Patients should not receive a "live vaccine" before, during, or after treatment with Venclexta, until the patient's doctor tells them it is okay. If the patient is not sure about the type of immunization or vaccine, the patient should ask their doctor. These vaccines may not be safe or may not work as well during treatment with Venclexta. Are pregnant or plan to become pregnant. Venclexta may harm an unborn baby. If the patient is able to become pregnant, the patient's doctor should do a pregnancy test before the patient starts treatment with Venclexta, and the patient should use effective birth control during treatment and for at least 30 days after the last dose of Venclexta. If the patient becomes pregnant or thinks they are pregnant, the patient should tell their doctor right away. Are breastfeeding or plan to breastfeed. It is not known if Venclexta passes into the patient's breast milk. Patients are instructed to not breastfeed during treatment with Venclexta and for 1 week after the last dose. What to avoid while taking Venclexta: Patients should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while they are taking Venclexta. These products may increase the amount of Venclexta in the patient's blood. What are the possible side effects of Venclexta? Venclexta can cause serious side effects, including: Low white blood cell counts (neutropenia). Low white blood cell counts are common with Venclexta, but can also be severe. The patient's doctor will do blood tests to check their blood counts during treatment with Venclexta and may pause dosing. Infections. Death and serious infections such as pneumonia and blood infection (sepsis) have happened during treatment with Venclexta. The patient's doctor will closely monitor and treat the patient right away if they have a fever or any signs of infection during treatment with Venclexta. Patients should tell their doctor right away if they have a fever or any signs of an infection during treatment with Venclexta. The most common side effects of Venclexta when used in combination with obinutuzumab or rituximab or alone in people with CLL or SLL include low white blood cell count; low platelet count; low red blood cell count; diarrhea; nausea; upper respiratory tract infection; cough; muscle and joint pain; tiredness; and swelling of arms, legs, hands, and feet. The most common side effects of Venclexta in combination with azacitidine or decitabine or low-dose cytarabine in people with AML include nausea; diarrhea; low platelet count; constipation; low white blood cell count; fever with low white blood cell count; tiredness; vomiting; swelling of arms, legs, hands, or feet; fever; infection in lungs; shortness of breath; bleeding; low red blood cell count; rash; stomach (abdominal) pain; infection in your blood; muscle and joint pain; dizziness; cough; sore throat; and low blood pressure. Venclexta may cause fertility problems in males. This may affect the ability to father a child. Patients should talk to their doctor if they have concerns about fertility. These are not all the possible side effects of Venclexta. Patients should call their doctor for medical advice about side effects. You may report side effects to the FDA at (800) FDA-1088 or You may also report side effects to Genentech at (888) 835-2555. Please see the Venclexta full Prescribing Information, including the Medication Guide, for additional Important Safety Information. About Genentech in Hematology For more than 20 years, Genentech has been developing medicines with the goal to redefine treatment in hematology. Today, we're investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. For more information visit About Genentech Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit View source version on Contacts Media Contact:Kristen Ingram, (650) 467-6800 Advocacy Contact:Catherine Creme Henry, (202) 745-5210 Investor Contacts:Loren Kalm, (650) 225-3217Bruno Eschli, +41 61 687 5284 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
5 days ago
- Business
- Business Wire
Genentech Provides Update on Phase III Verona Study
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and AbbVie announced today the outcome from the Phase III VERONA study (NCT04401748) investigating Venclexta ® (venetoclax) plus azacitidine for patients with previously untreated higher-risk myelodysplastic syndromes (MDS). The study did not meet the primary endpoint of overall survival at the final analysis. The safety profile of the Venclexta combination was consistent with the known risk of the individual study medicines and no unexpected safety signals were observed. Full data will be presented at an upcoming medical meeting in 2025. VERONA is a global, AbbVie-led, Phase III, multicenter, randomized, double-blind study evaluating Venclexta in combination with azacitidine compared to placebo plus azacitidine in treatment-naïve patients with higher-risk MDS. The study includes approximately 500 patients across 220 sites globally who were randomly assigned to either Venclexta plus azacitidine or placebo plus azacitidine. Patients who received Venclexta in combination with azacitidine through participation in the MDS clinical trials will be informed by their treating physician. The results of the VERONA study have no impact on the approved indications for Venclexta or any ongoing studies. About Venclexta ® (venetoclax) Venclexta is a first-in-class targeted medicine designed to bind selectively and inhibit the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers and other tumors, BCL-2 builds up and prevents cancer cells from dying or self-destructing, a process called apoptosis. Venclexta blocks the BCL-2 protein and works to help restore the process of apoptosis. Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the United States and commercialized by AbbVie outside of the United States. Together, the companies are committed to research with Venclexta, which is currently being studied in clinical trials across several types of blood cancers. Venclexta ® (venetoclax) U.S. Indication Venclexta is a prescription medicine used: to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who: are 75 years of age or older, or have other medical conditions that prevent the use of standard chemotherapy. It is not known if Venclexta is safe and effective in children. Important Safety Information What is the most important information patients should know about Venclexta? Venclexta can cause serious side effects, including: Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. The patient's doctor will do tests to check their risk of getting TLS before they start taking Venclexta. The patient will receive other medicines before starting and during treatment with Venclexta to help reduce the risk of TLS. The patient may also need to receive intravenous (IV) fluids into their vein. The patient's doctor will do blood tests to check for TLS when the patient first starts treatment and during treatment with Venclexta. It is important for patients to keep appointments for blood tests. Patients should tell their doctor right away if they have any symptoms of TLS during treatment with Venclexta, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain. Patients should drink plenty of water during treatment with Venclexta to help reduce the risk of getting TLS. Patients should drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before the first dose on the day of the first dose of Venclexta, and each time a dose is increased. The patient's doctor may delay, decrease the dose, or stop treatment with Venclexta if the patient has side effects. When restarting Venclexta after stopping for 1 week or longer, the patient's doctor may again check for the risk of TLS and change the patient's dose. What patients should not take Venclexta? Certain medicines must not be taken when the patient first starts taking Venclexta and while the dose is being slowly increased because of the risk of increased TLS. Patients should tell their doctor about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Venclexta and other medicines may affect each other causing serious side effects. Patients must not start new medicines during treatment with Venclexta without first talking with their doctor. Before taking Venclexta, patients must tell their doctor about all of their medical conditions, including if they: Have kidney or liver problems. Have problems with body salts or electrolytes, such as potassium, phosphorus, or calcium. Have a history of high uric acid levels in the blood or gout. Are scheduled to receive a vaccine. Patients should not receive a 'live vaccine' before, during, or after treatment with Venclexta, until the patient's doctor tells them it is okay. If the patient is not sure about the type of immunization or vaccine, the patient should ask their doctor. These vaccines may not be safe or may not work as well during treatment with Venclexta. Are pregnant or plan to become pregnant. Venclexta may harm an unborn baby. If the patient is able to become pregnant, the patient's doctor should do a pregnancy test before the patient starts treatment with Venclexta, and the patient should use effective birth control during treatment and for at least 30 days after the last dose of Venclexta. If the patient becomes pregnant or thinks they are pregnant, the patient should tell their doctor right away. Are breastfeeding or plan to breastfeed. It is not known if Venclexta passes into the patient's breast milk. Patients are instructed to not breastfeed during treatment with Venclexta and for 1 week after the last dose. What to avoid while taking Venclexta: Patients should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while they are taking Venclexta. These products may increase the amount of Venclexta in the patient's blood. What are the possible side effects of Venclexta? Venclexta can cause serious side effects, including: Low white blood cell counts (neutropenia). Low white blood cell counts are common with Venclexta, but can also be severe. The patient's doctor will do blood tests to check their blood counts during treatment with Venclexta and may pause dosing. Infections. Death and serious infections such as pneumonia and blood infection (sepsis) have happened during treatment with Venclexta. The patient's doctor will closely monitor and treat the patient right away if they have a fever or any signs of infection during treatment with Venclexta. Patients should tell their doctor right away if they have a fever or any signs of an infection during treatment with Venclexta. The most common side effects of Venclexta when used in combination with obinutuzumab or rituximab or alone in people with CLL or SLL include low white blood cell count; low platelet count; low red blood cell count; diarrhea; nausea; upper respiratory tract infection; cough; muscle and joint pain; tiredness; and swelling of arms, legs, hands, and feet. The most common side effects of Venclexta in combination with azacitidine or decitabine or low-dose cytarabine in people with AML include nausea; diarrhea; low platelet count; constipation; low white blood cell count; fever with low white blood cell count; tiredness; vomiting; swelling of arms, legs, hands, or feet; fever; infection in lungs; shortness of breath; bleeding; low red blood cell count; rash; stomach (abdominal) pain; infection in your blood; muscle and joint pain; dizziness; cough; sore throat; and low blood pressure. Venclexta may cause fertility problems in males. This may affect the ability to father a child. Patients should talk to their doctor if they have concerns about fertility. These are not all the possible side effects of Venclexta. Patients should call their doctor for medical advice about side effects. You may report side effects to the FDA at (800) FDA-1088 or You may also report side effects to Genentech at (888) 835-2555. Please see the Venclexta full Prescribing Information, including the Medication Guide, for additional Important Safety Information. About Genentech in Hematology For more than 20 years, Genentech has been developing medicines with the goal to redefine treatment in hematology. Today, we're investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. For more information visit About Genentech Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://
Yahoo
5 days ago
- Business
- Yahoo
Genentech Provides Update on Phase III Verona Study
SOUTH SAN FRANCISCO, Calif., June 16, 2025--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and AbbVie announced today the outcome from the Phase III VERONA study (NCT04401748) investigating Venclexta® (venetoclax) plus azacitidine for patients with previously untreated higher-risk myelodysplastic syndromes (MDS). The study did not meet the primary endpoint of overall survival at the final analysis. The safety profile of the Venclexta combination was consistent with the known risk of the individual study medicines and no unexpected safety signals were observed. Full data will be presented at an upcoming medical meeting in 2025. VERONA is a global, AbbVie-led, Phase III, multicenter, randomized, double-blind study evaluating Venclexta in combination with azacitidine compared to placebo plus azacitidine in treatment-naïve patients with higher-risk MDS. The study includes approximately 500 patients across 220 sites globally who were randomly assigned to either Venclexta plus azacitidine or placebo plus azacitidine. Patients who received Venclexta in combination with azacitidine through participation in the MDS clinical trials will be informed by their treating physician. The results of the VERONA study have no impact on the approved indications for Venclexta or any ongoing studies. About Venclexta® (venetoclax) Venclexta is a first-in-class targeted medicine designed to bind selectively and inhibit the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers and other tumors, BCL-2 builds up and prevents cancer cells from dying or self-destructing, a process called apoptosis. Venclexta blocks the BCL-2 protein and works to help restore the process of apoptosis. Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the United States and commercialized by AbbVie outside of the United States. Together, the companies are committed to research with Venclexta, which is currently being studied in clinical trials across several types of blood cancers. Venclexta® (venetoclax) U.S. Indication Venclexta is a prescription medicine used: to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who: are 75 years of age or older, or have other medical conditions that prevent the use of standard chemotherapy. It is not known if Venclexta is safe and effective in children. Important Safety Information What is the most important information patients should know about Venclexta? Venclexta can cause serious side effects, including: Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. The patient's doctor will do tests to check their risk of getting TLS before they start taking Venclexta. The patient will receive other medicines before starting and during treatment with Venclexta to help reduce the risk of TLS. The patient may also need to receive intravenous (IV) fluids into their vein. The patient's doctor will do blood tests to check for TLS when the patient first starts treatment and during treatment with Venclexta. It is important for patients to keep appointments for blood tests. Patients should tell their doctor right away if they have any symptoms of TLS during treatment with Venclexta, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain. Patients should drink plenty of water during treatment with Venclexta to help reduce the risk of getting TLS. Patients should drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before the first dose on the day of the first dose of Venclexta, and each time a dose is increased. The patient's doctor may delay, decrease the dose, or stop treatment with Venclexta if the patient has side effects. When restarting Venclexta after stopping for 1 week or longer, the patient's doctor may again check for the risk of TLS and change the patient's dose. What patients should not take Venclexta? Certain medicines must not be taken when the patient first starts taking Venclexta and while the dose is being slowly increased because of the risk of increased TLS. Patients should tell their doctor about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Venclexta and other medicines may affect each other causing serious side effects. Patients must not start new medicines during treatment with Venclexta without first talking with their doctor. Before taking Venclexta, patients must tell their doctor about all of their medical conditions, including if they: Have kidney or liver problems. Have problems with body salts or electrolytes, such as potassium, phosphorus, or calcium. Have a history of high uric acid levels in the blood or gout. Are scheduled to receive a vaccine. Patients should not receive a "live vaccine" before, during, or after treatment with Venclexta, until the patient's doctor tells them it is okay. If the patient is not sure about the type of immunization or vaccine, the patient should ask their doctor. These vaccines may not be safe or may not work as well during treatment with Venclexta. Are pregnant or plan to become pregnant. Venclexta may harm an unborn baby. If the patient is able to become pregnant, the patient's doctor should do a pregnancy test before the patient starts treatment with Venclexta, and the patient should use effective birth control during treatment and for at least 30 days after the last dose of Venclexta. If the patient becomes pregnant or thinks they are pregnant, the patient should tell their doctor right away. Are breastfeeding or plan to breastfeed. It is not known if Venclexta passes into the patient's breast milk. Patients are instructed to not breastfeed during treatment with Venclexta and for 1 week after the last dose. What to avoid while taking Venclexta: Patients should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while they are taking Venclexta. These products may increase the amount of Venclexta in the patient's blood. What are the possible side effects of Venclexta? Venclexta can cause serious side effects, including: Low white blood cell counts (neutropenia). Low white blood cell counts are common with Venclexta, but can also be severe. The patient's doctor will do blood tests to check their blood counts during treatment with Venclexta and may pause dosing. Infections. Death and serious infections such as pneumonia and blood infection (sepsis) have happened during treatment with Venclexta. The patient's doctor will closely monitor and treat the patient right away if they have a fever or any signs of infection during treatment with Venclexta. Patients should tell their doctor right away if they have a fever or any signs of an infection during treatment with Venclexta. The most common side effects of Venclexta when used in combination with obinutuzumab or rituximab or alone in people with CLL or SLL include low white blood cell count; low platelet count; low red blood cell count; diarrhea; nausea; upper respiratory tract infection; cough; muscle and joint pain; tiredness; and swelling of arms, legs, hands, and feet. The most common side effects of Venclexta in combination with azacitidine or decitabine or low-dose cytarabine in people with AML include nausea; diarrhea; low platelet count; constipation; low white blood cell count; fever with low white blood cell count; tiredness; vomiting; swelling of arms, legs, hands, or feet; fever; infection in lungs; shortness of breath; bleeding; low red blood cell count; rash; stomach (abdominal) pain; infection in your blood; muscle and joint pain; dizziness; cough; sore throat; and low blood pressure. Venclexta may cause fertility problems in males. This may affect the ability to father a child. Patients should talk to their doctor if they have concerns about fertility. These are not all the possible side effects of Venclexta. Patients should call their doctor for medical advice about side effects. You may report side effects to the FDA at (800) FDA-1088 or You may also report side effects to Genentech at (888) 835-2555. Please see the Venclexta full Prescribing Information, including the Medication Guide, for additional Important Safety Information. About Genentech in Hematology For more than 20 years, Genentech has been developing medicines with the goal to redefine treatment in hematology. Today, we're investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. For more information visit About Genentech Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit View source version on Contacts Media Contact:Kristen Ingram, (650) 467-6800 Advocacy Contact:Catherine Creme Henry, (202) 745-5210 Investor Contacts:Loren Kalm, (650) 225-3217Bruno Eschli, +41 61 687 5284 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
