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6-K: Blenrep Combinations Accepted for Review by the Us Fda for the Treatment of Relapsed/Refractory Multiple Myeloma

6-K: Blenrep Combinations Accepted for Review by the Us Fda for the Treatment of Relapsed/Refractory Multiple Myeloma

6-K：美国FDA接受Blenrep组合疗法的审查，用于治疗复发/难治性多发性骨髓瘤
美股SEC公告 ·  2024/11/25 07:17

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The FDA has accepted GSK's Biologics License Application for Blenrep combinations with BorDex and PomDex for treating multiple myeloma patients who received at least one prior therapy. The review is supported by phase III DREAMM-7 and DREAMM-8 trials, with a decision expected by July 23, 2025. This marks the sixth major regulatory filing acceptance for belantamab mafodotin combinations this year.Both DREAMM-7 and DREAMM-8 trials met their primary endpoints, demonstrating significant improvements in progression-free survival compared to standard care. Notably, DREAMM-7 achieved statistically significant overall survival benefit, while DREAMM-8 showed a positive trend. The safety profiles were consistent with the known profiles of individual agents.The treatment combinations have already gained regulatory acceptance in multiple regions, including the EU, Japan (with priority review), UK, Canada, and Switzerland. In China, the therapy received Breakthrough Therapy Designation and priority review based on DREAMM-7 results.
The FDA has accepted GSK's Biologics License Application for Blenrep combinations with BorDex and PomDex for treating multiple myeloma patients who received at least one prior therapy. The review is supported by phase III DREAMM-7 and DREAMM-8 trials, with a decision expected by July 23, 2025. This marks the sixth major regulatory filing acceptance for belantamab mafodotin combinations this year.Both DREAMM-7 and DREAMM-8 trials met their primary endpoints, demonstrating significant improvements in progression-free survival compared to standard care. Notably, DREAMM-7 achieved statistically significant overall survival benefit, while DREAMM-8 showed a positive trend. The safety profiles were consistent with the known profiles of individual agents.The treatment combinations have already gained regulatory acceptance in multiple regions, including the EU, Japan (with priority review), UK, Canada, and Switzerland. In China, the therapy received Breakthrough Therapy Designation and priority review based on DREAMM-7 results.
美国FDA已接受GSK针对多发性骨髓瘤患者（至少接受过一种治疗）的Blenrep与BorDex和PomDex组合的生物制品许可证申请。此次审查得到了III期DREAMm-7和DREAMm-8试验的支持，预计将在2025年7月23日前作出决定。这标志着今年针对belantamab mafodotin组合的第六次重大监管申请被接受。DREAMm-7和DREAMm-8试验都达到了其主要终点，与标准治疗相比，显示了无进展生存期的显著改善。值得注意的是，DREAMm-7取得了统计学上显著的总体生存益处，而DREAMm-8显示出积极的趋势。安全性分析与已知个别药物的安全性特征一致。这些治疗组合在多个地区（包括欧盟、日本（优先审查）、英国、加拿大和瑞士）已经获得监管认可。在中国，根据DREAMm-7的结果，该疗法获得了突破性疗法认定和优先审查。
美国FDA已接受GSK针对多发性骨髓瘤患者（至少接受过一种治疗）的Blenrep与BorDex和PomDex组合的生物制品许可证申请。此次审查得到了III期DREAMm-7和DREAMm-8试验的支持，预计将在2025年7月23日前作出决定。这标志着今年针对belantamab mafodotin组合的第六次重大监管申请被接受。DREAMm-7和DREAMm-8试验都达到了其主要终点，与标准治疗相比，显示了无进展生存期的显著改善。值得注意的是，DREAMm-7取得了统计学上显著的总体生存益处，而DREAMm-8显示出积极的趋势。安全性分析与已知个别药物的安全性特征一致。这些治疗组合在多个地区（包括欧盟、日本（优先审查）、英国、加拿大和瑞士）已经获得监管认可。在中国，根据DREAMm-7的结果，该疗法获得了突破性疗法认定和优先审查。
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