Bendamustine Hydrochloride

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved CD20xCD3 bispecific Lunsumio VELO™ (mosunetuzumab-axgb), as a subcutaneous (SC) formulation, for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy, based on results from the Phase I/II GO29781 study. Based on the study results, Lunsumio VELO is approved under accelerated approval. Full approval for this regimen may be contingent on verification and confirmation of benefit in a confirmatory trial. “Since follicular lymphoma often requires lifelong management, reducing the burden of care for these individuals is of paramount importance,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “With this FDA approval, treatment can now be administered in just one minute, which significantly reduces the time patients spend in the clinic and helps to align care with their individual needs and preferences.” Lunsumio VELO reduces administration time with an approximately one-minute injection, compared with a 2-4 hour intravenous (IV) infusion. Like Lunsumio administered intravenously, Lunsumio VELO can be administered outpatient and is a fixed-duration treatment given for a defined period, which could be as short as six months. By contrast, treat-to-progression treatment options are designed to be given to patients indefinitely until disease progression or until treatment can no longer be tolerated. “This approval is a significant step in broadening access to effective treatments for people living with follicular lymphoma,” said Dr. Ian Flinn, M.D., Ph.D., Tennessee Oncology and One Oncology. “With its manageable cytokine release syndrome profile and reduced administration time, Lunsumio VELO enables oncologists to deliver advanced care in community practice settings.” The FDA approval is supported by the primary analysis of the GO29781 study that evaluated Lunsumio VELO in patients with third-line or later (3L+) FL. Results showed the objective response rate and complete response rate in patients treated with Lunsumio VELO were 75% (95% confidence interval [CI]: 64–83%) and 59% (95% CI: 48–69%), respectively. The median duration of response was 22.4 months (95% CI: 16.8–22.8). The most common adverse reactions (≥20%) were injection site reactions, fatigue, rash, cytokine release syndrome (CRS), COVID-19 infection, musculoskeletal pain and diarrhea. The CRS rate was 30% and events were mostly low grade (Grade 1–2, 28%; Grade 3, 2.1%), occurred during Cycle 1, and all resolved after a median duration of two days (range: 1–15). CRS can be severe and life-threatening. Lunsumio IV was the first bispecific antibody approved for 3L+ FL. Long-term data from the SC and IV arms of the GO29781 study were presented at the 67th American Society of Hematology Annual Meeting and Exposition. These data have been submitted to other healthcare authorities around the world. Recently, the European Commission granted conditional marketing authorization of Lunsumio SC for the treatment of adult patients with R/R FL after two or more lines of systemic therapy. Genentech continues to advance its bispecific antibody program in lymphoma, with ongoing Phase III studies evaluating Lunsumio and Lunsumio VELO in earlier lines of treatment. This includes the SUNMO study investigating Lunsumio VELO in combination with Polivy® (polatuzumab vedotin-piiq) in second-line or later large B-cell lymphoma, and the MorningLyte study investigating Lunsumio VELO in combination with lenalidomide in previously untreated FL. Genentech is committed to helping patients get the medicine their doctor prescribed. For people who qualify, Genentech plans to offer patient assistance programs through Genentech Access Solutions. More information is also available at 866-4ACCESS/866-422-2377 or http://www.Genentech-Access.com. About the GO29781 Study The GO29781 [NCT02500407] study is a Phase I/II, multicenter, open-label, dose-escalation and expansion study evaluating the safety, efficacy, and pharmacokinetics of mosunetuzumab-axgb administered both as an intravenous (IV) and subcutaneous (SC) treatment, in people with relapsed or refractory B-cell non-Hodgkin lymphoma. The efficacy of Lunsumio VELO was established on the basis of objective response rate and duration of response. About Follicular Lymphoma (FL) Follicular lymphoma (FL) is the most common slow-growing (indolent) form of non-Hodgkin lymphoma, accounting for about one in five cases. It typically responds well to treatment but is often characterized by periods of remission and relapse. The disease typically becomes harder to treat each time a patient relapses and early progression can be associated with poor long-term prognosis. It is estimated that, in the United States, approximately 13,000 new cases of FL will be diagnosed in 2025 and more than 110,000 people are diagnosed with FL each year worldwide. About Lunsumio VELO™ (mosunetuzumab-axgb) Lunsumio VELO™ is a subcutaneous formulation of mosunetuzumab-axgb, a 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. Lunsumio VELO is being investigated as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin lymphomas, including follicular lymphoma, large B-cell lymphoma, and other indications. Lunsumio and Lunsumio VELO U.S. Indication LUNSUMIO (mosunetuzumab-axgb) or LUNSUMIO VELO 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. It is not known if LUNSUMIO or LUNSUMIO VELO is safe and effective in children. The conditional approval for this use is based on response rate. There are ongoing studies to establish how well the drug works. Important Safety Information What is the most important information I should know about LUNSUMIO or LUNSUMIO VELO? LUNSUMIO or LUNSUMIO VELO can cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with LUNSUMIO or LUNSUMIO VELO, 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 or LUNSUMIO VELO on a “step-up dosing schedule.” The step-up dosing schedule is when you receive smaller “step-up” doses before receiving higher doses of LUNSUMIO or LUNSUMIO VELO during your first cycle of treatment If your dose of LUNSUMIO or LUNSUMIO VELO is delayed for any reason, you may need to repeat the “step-up dosing schedule” You may receive medicines to help reduce your risk of CRS before your dose Your healthcare provider will check you for CRS during treatment with LUNSUMIO or LUNSUMIO VELO 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 or LUNSUMIO VELO, if you have severe side effects. What are the possible side effects of LUNSUMIO or LUNSUMIO VELO? LUNSUMIO or LUNSUMIO VELO can cause serious side effects, including: Neurologic problems. LUNSUMIO or LUNSUMIO VELO can cause serious and life-threatening neurologic problems. Your healthcare provider will check you for neurologic problems during treatment with LUNSUMIO or LUNSUMIO VELO. 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 or LUNSUMIO VELO, 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 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 or LUNSUMIO VELO 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 or LUNSUMIO VELO, 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 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 or LUNSUMIO VELO 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 or LUNSUMIO VELO. Your healthcare 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 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 or LUNSUMIO VELO and can also be serious or severe. Your healthcare provider will check your blood cell counts during treatment with LUNSUMIO or LUNSUMIO VELO. LUNSUMIO or LUNSUMIO VELO can cause the following low blood cell counts: low white blood cell counts (lymphopenia [for LUNSUMIO VELO only] and 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 low white blood cell counts (lymphopenia [for LUNSUMIO VELO only] and 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 or LUNSUMIO VELO 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 or LUNSUMIO VELO: chest pain cough trouble breathing tender or swollen lymph nodes pain or swelling at the site of the tumor 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 or LUNSUMIO VELO if you develop severe side effects. The most common side effects of LUNSUMIO include: CRS, tiredness, rash, headache, fever, muscle pain, cough, itching, and numbness, tingling, or pain in the hands or feet (nerve damage). The most common side effects of LUNSUMIO VELO include: injection site reactions, tiredness, rash, CRS, COVID-19, muscle and joint pain, and diarrhea. The most common severe abnormal blood test results with LUNSUMIO include: decreased phosphate, increased glucose, and increased uric acid levels. The most common severe abnormal blood test results with LUNSUMIO VELO include: decreased white blood cell counts and increased uric acid levels. Before receiving LUNSUMIO or LUNSUMIO VELO, 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 or LUNSUMIO VELO 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 or LUNSUMIO VELO Females who are able to become pregnant: your healthcare provider should do a pregnancy test before you start treatment with LUNSUMIO or LUNSUMIO VELO use an effective method of birth control (contraception) during your treatment and for 3 months after the last dose of LUNSUMIO or LUNSUMIO VELO your healthcare provider should do a pregnancy test before you start treatment with LUNSUMIO or LUNSUMIO VELO use an effective method of birth control (contraception) during your treatment and for 3 months after the last dose of LUNSUMIO or LUNSUMIO VELO are breastfeeding or plan to breastfeed. It is not known if LUNSUMIO or LUNSUMIO VELO passes into your breast milk. Do not breastfeed during treatment and for 3 months after the last dose of LUNSUMIO or LUNSUMIO VELO 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 or LUNSUMIO VELO? 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 of the possible side effects of LUNSUMIO or LUNSUMIO VELO. Talk to your healthcare provider for more information about the benefits and risks of LUNSUMIO or LUNSUMIO VELO. You may report side effects to the FDA at (800) FDA-1088 or https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program. 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 and LUNSUMIO VELO full Prescribing Information and Medication Guide and on https://www.Lunsumio.com. About Polivy® (polatuzumab vedotin-piiq) Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed specifically 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 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. 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 https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program. You may also report side effects to Genentech at (888) 835-2555. Please see the full Prescribing Information and visit https://www.Polivy.com 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 http://www.gene.com/hematology. About Genentech Founded nearly 50 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://www.gene.com.

FT819持续展现显著疾病缓解效果与良好安全性，已治疗12例系统性红斑狼疮（SLE）患者；首例系统性硬化症（SSc）患者完成给药 首例美国境外SLE患者接受FT819治疗，拓宽了患者入组范围，彰显其广泛、按需可及的独特优势 临床前研究显示，靶向应激抗原MICA/B的FT836嵌合抗原受体（CAR）T细胞联合达雷妥尤单抗，为多发性骨髓瘤治疗提供全面解决方案 FT839 CAR-T细胞通过双CAR靶向CD19/CD38，在多种临床前模型中无需预处理化疗即可治疗多种B细胞恶性肿瘤及自身免疫性疾病；联合单克隆抗体或T细胞衔接器可进一步扩大靶向范围 12月18日消息，专注于开发首款诱导多能干细胞（iPSC）来源现货型细胞免疫疗法、实现患者广泛可及的临床阶段生物制药公司Fate Therapeutics, Inc.（纳斯达克代码：FATE），在佛罗里达州奥兰多举行的2025年美国血液学会（ASH）年会上，公布了其在研FT819现货型iPSC来源CAR-T疗法用于系统性红斑狼疮（SLE）治疗的1期临床试验更新数据，并披露了下一代现货型iPSC来源CAR-T疗法用于血液系统恶性肿瘤及自身免疫性疾病治疗的最新临床前研究成果。 Fate Therapeutics总裁兼首席执行官Bob Valamehr博士、工商管理硕士表示：“我们对患者入组加速、美国临床研究中心扩展及国际研究中心的新增感到非常满意，这些进展共同推动FT819为更多狼疮患者带来治疗希望。FT819的更新临床数据持续显示，在采用低强度预处理化疗的情况下，该疗法可实现显著且持久的疗效响应，同时具备差异化的安全性特征。这不仅坚定了我们2026年启动FT819注册临床试验的目标，也凸显了其作为多种自身免疫性疾病理想CAR-T疗法的潜力。与此同时，我们的下一代管线FT836和FT839取得了实质性进展，通过增强药效、延长功能持久性及多功能工程设计，有望将我们平台的获益范围拓展至血液系统恶性肿瘤和实体瘤领域。这些突破彰显了我们iPSC来源现货型CAR-T管线的持续发展势头，也体现了我们致力于向全球患者提供可规模化、按需获取且广泛可及的CAR-T疗法的坚定承诺。” 本次临床更新数据来自该公司正在进行的FT819 1期篮子试验，共纳入13例患者，其中12例为SLE患者（10例已完成至少1个月的治疗后随访），1例为系统性硬化症患者。 更新结果显示，该疗法可实现持续的临床响应，以潜在的剂量依赖性方式实现持久的B细胞耗竭，且无需采用高强度预处理化疗（通常为多日环磷酰胺联合氟达拉滨给药）即具备差异化的安全性特征。 基于这一优异的临床数据，公司持续推进关键试验的筹备工作，并正就2026年启动FT819注册临床试验的相关计划，与美国食品药品监督管理局（FDA）在再生医学先进疗法（RMAT）认定框架下开展沟通。 在ASH年会上，公司还公布了两款下一代iPSC来源CAR-T疗法的最新临床前数据，这些疗法均针对肿瘤和自身免疫性疾病治疗设计。与现有自体及体内CAR-T平台相比，这些管线在功能活性、持久性、药物产品一致性、抗原靶向机制广度等方面均展现出实质性提升。 FT819-102临床试验更新 FT819是一款靶向CD19的现货型嵌合抗原受体（CAR）T细胞产品，通过工程化设计提升了安全性与疗效。与用于大规模生产单克隆抗体等生物制药产品的主细胞系类似，FT819以精准工程化的克隆iPSC主细胞系为起始细胞来源进行生产，克服了患者来源及供体来源CAR-T疗法的诸多局限性。FT819成分明确、均一，生产成本低，可库存储存，实现现货供应、按需获取，有望惠及广泛患者群体。 截至2025年11月25日数据截止日，已有5家研究中心完成12例SLE患者给药，目前共激活14家临床研究中心（其中美国11家、英国3家）。入组患者基线特征符合高疾病负荷人群特征： - 系统性红斑狼疮中位病程8.7年，中位既往治疗方案数7种； - 系统性红斑狼疮疾病活动指数2000（SLEDAI-2K）中位值为14（基线范围8-20）； - 医师整体评估（PGA）均值为2.3±0.4； - 慢性疾病治疗功能评估-疲劳量表（FACIT-Fatigue）均值为23±13。 截至2025年10月22日数据截止日，10例SLE患者完成至少1个月随访，其中6例为活动性狼疮肾炎患者。方案A（患者在接受单剂FT819给药前，先接受单剂环磷酰胺或两剂苯达莫司汀预处理）的初步数据显示，两个剂量水平（DL1：3.6亿个细胞；DL2：9亿个细胞）的患者SLEDAI-2K评分均较基线持续下降： - DL1组：SLEDAI-2K评分均值从基线的15.2（n=5）降至3个月时的10（n=2），6个月时进一步降至6（n=2），降幅分别达50%和70%； - DL2组：SLEDAI-2K评分均值从基线的14.3（n=3）降至3个月时的6（n=2），6个月时降至4（n=1），降幅分别达65%和78%。 10例患者中有5例实现临床SLEDAI-2K评分（排除抗dsDNA抗体和补体指标）为0，其中2例患者此前接受过免疫抑制剂治疗但未能达到该评分标准，在接受FT819治疗后成功达标。2例狼疮肾炎患者随访时间超过3个月，分别在治疗后2个月和6个月达到完全肾脏缓解（CRR）。 所有完成多次评估的患者，其FACIT-疲劳评分均得到显著改善。研究中观察到明显的B细胞耗竭，且在治疗后前3个月内，B细胞重构以初始细胞为主。未观察到剂量限制性毒性；无≥3级细胞因子释放综合征（CRS）、免疫效应细胞相关神经毒性综合征（ICANS）或移植物抗宿主病（GVHD）报告。所有患者均接受了按需供应的FT819治疗。 【图文来源网络免责声明】平台旨在分享医学细胞知识，版权归原作者及原出处所有，内容仅为作者观点，并不代表本公众号立场。如涉及版权等问题，请联系我们及时处理。文章旨在知识交流与分享；不代表我们的立场也不作为相关医疗指导或用药建议，仅作参考。