
Based on the results of the Phase 3 CARTITUDE-4 study, the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 11-0 in favor of a positive risk-benefit assessment for Carvykti®.
Based on the results of the Phase 3 CARTITUDE-4 study, the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 11-0 in favor of a positive risk-benefit assessment for Carvykti®.
At 8:30 pm Beijing time on March 15, 2024, the FDA’s Oncologic Drugs Advisory Committee (ODAC) officially convened, with the meeting lasting over 9 hours.
Last week, the FDA released briefing documents from the Oncologic Drugs Advisory Committee (ODAC) meeting regarding Johnson & Johnson’s Carvykti (Ciltacabtagene autoleucel) and Bristol-Myers Squibb’s Abecma (Idecabtagene vicleucel), two CAR-T therapies. The documents highlighted the FDA’s concern over the higher early mortality rates observed in the treatment arms compared to the control arms in the clinical trials for these two CAR-T therapies.
🌎Another BCMA CAR-T therapy for multiple myeloma hits the market in China! – 🔥Long-term efficacy 🔥 🌙China has made significant breakthroughs in the treatment of multiple myeloma with BCMA CAR-T therapy, attracting global attention. Recently, two fully human BCMA CAR-T therapies, Equecabtagene Autoleucel and Zevorcabtagene Autoleucel, have been approved for the treatment Read More
Another BCMA CAR-T therapy for multiple myeloma hits the market in China! – Short-term efficacy China CAR-T therapy In recent years, CAR-T cell therapy has achieved tremendous success in treating hematologic malignancies. Over the past 11 years, China has seen a surge in clinical trials evaluating the safety and efficacy of CAR-T therapy. Read More
On March 16, 2024, Legend Biotech announced that the U.S. FDA Oncologic Drugs Advisory Committee (ODAC) unanimously recommended, with a vote of 11:0, the approval of CARVYKTI® (Ciltacabtagene Autoleucel, cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy (including a proteasome inhibitor and an immunomodulatory agent) and are refractory to lenalidomide.
Cross-Border Medical Innovation: Singaporean Patient Confronts Multiple Myeloma in China – A Decisive Journey with CAR-T Therapy Singaporean patient, Teresa has been battling multiple myeloma for nearly three years. Despite undergoing various conventional treatments including multi-drug therapy, radiation, and chemotherapy, her condition relapsed with extramedullary plasmacytomas affecting her brain, liver, and multiple bones. Read More
跨境医疗创新:新加坡患者在中国迎战骨髓瘤——一次CAR-T治疗的决定性旅程 新加坡患者Teresa女士,经历了近三年与多发性骨髓瘤的斗争,她目前在多线药物治疗、放化疗后仍面临病情复发,髓外浆细胞瘤同时伴有脑、肝、多处骨病变。近期,她在接受上海嘉会国际医院的Dr. Vicky Lee及其团队线上会诊后,做出了一个重要决定:到中国接受FUCASO CAR-T治疗。 中国不仅在CAR-T治疗领域具有全球领先的临床经验,还有处于全球价格洼地的优质商业化CAR-T产品。目前这些已在中国上市的CAR-T产品产能充足,这对于与死神竞速的患者来说至关重要。同时因其仅一针输注的便捷性,已经备受国际患者的关注。 在上海嘉会国际医院,经验丰富的血液肿瘤专家团队将为Teresa制定个性化的治疗方案,并提供全程、精细化的诊疗服务。作为CAR-T治疗的先行者,嘉会医院即将为Teresa女士带来新生的希望。 我们将持续关注患者的治疗后续,并跟进报道。 #CART #CARTTherapy #HopeReborn #FUCASOApproval #Equecel #MultipleMyeloma #JiahuiHospital #Shanghai #Immunotherapy #MedicalInnovation #MedicalBreakthrough #CancerTreatment #FullyHumanCART #与癌症抗争 #CART治疗之旅 #携手嘉会 #全人源CAR-T #健康重生 #共同祈愿 #骨髓瘤 #多发性骨髓瘤 #Multiplemyeloma #患者故事 #HopeForPatients
On February 28, 2022, Legend Biotech Corporation (LEGN) announced that the U.S. Food and Drug Administration (FDA) has approved its first product, CARVYKTI™ (ciltacabtagene autoleucel; cilta-cel), for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
🍒🍎Journey of an Indian Cancer Patient to China: Bringing Gratitude Back to India!🍒🍎 🍅“Before coming to China for treatment, I had many concerns because my condition was very pessimistic at that time. I was worried that I might never see my family again… But since I arrived here, everyone I met has been welcoming. The Read More
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