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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 20:17

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GSK announced FDA acceptance of Blenrep (belantamab mafodotin) combinations for review in relapsed/refractory multiple myeloma treatment. The application, supported by DREAMM-7 and DREAMM-8 phase III trials, showed significant improvements in progression-free survival and overall survival (DREAMM-7) compared to standard care. The FDA decision is expected by July 23, 2025.The submission is based on DREAMM-7 and DREAMM-8 trials, which met primary endpoints with statistically significant improvements in progression-free survival. DREAMM-7 also showed a significant overall survival benefit. Safety profiles were consistent with known individual agent profiles. This marks the sixth major regulatory filing acceptance for Blenrep combinations in 2024, including EU, Japan, UK, Canada, and Switzerland.Multiple myeloma, the third most common blood cancer globally, remains a significant health concern with over 35,000 new cases expected in the US in 2024. If approved, Blenrep combinations could redefine treatment at or after first relapse, offering new options for patients with manageable side effects and community-based administration.
GSK announced FDA acceptance of Blenrep (belantamab mafodotin) combinations for review in relapsed/refractory multiple myeloma treatment. The application, supported by DREAMM-7 and DREAMM-8 phase III trials, showed significant improvements in progression-free survival and overall survival (DREAMM-7) compared to standard care. The FDA decision is expected by July 23, 2025.The submission is based on DREAMM-7 and DREAMM-8 trials, which met primary endpoints with statistically significant improvements in progression-free survival. DREAMM-7 also showed a significant overall survival benefit. Safety profiles were consistent with known individual agent profiles. This marks the sixth major regulatory filing acceptance for Blenrep combinations in 2024, including EU, Japan, UK, Canada, and Switzerland.Multiple myeloma, the third most common blood cancer globally, remains a significant health concern with over 35,000 new cases expected in the US in 2024. If approved, Blenrep combinations could redefine treatment at or after first relapse, offering new options for patients with manageable side effects and community-based administration.
GSk宣布FDA接受Blenrep（belantamab mafodotin）联合治疗复发/难治性多发性骨髓瘤的申请进行审查。该申请获得了DREAMm-7和DREAMm-8三期试验的支持，显示在无进展生存期和整体生存期（DREAMm-7）方面相比于标准治疗有显著改善。FDA的决定预计在2025年7月23日之前公布。该提交基于DREAMm-7和DREAMm-8试验，这些试验满足了主要终点，进展性生存期有统计学上的显著改善。DREAMm-7还显示出明显的整体生存获益。安全性特征与已知个体药物特征一致。这标志着2024年Blenrep联合治疗第六次主要监管申请被接受，包括欧盟、日本、英国、加拿大和瑞士。多发性骨髓瘤是全球第三大常见血癌，仍然是一个重要的健康问题，预计在2024年美国将有超过35,000个新病例。如果获批，Blenrep联合疗法可能会重新定义首次复发时或之后的治疗，为患者提供新的选择，副作用可控且可以在社区进行管理。
GSk宣布FDA接受Blenrep（belantamab mafodotin）联合治疗复发/难治性多发性骨髓瘤的申请进行审查。该申请获得了DREAMm-7和DREAMm-8三期试验的支持，显示在无进展生存期和整体生存期（DREAMm-7）方面相比于标准治疗有显著改善。FDA的决定预计在2025年7月23日之前公布。该提交基于DREAMm-7和DREAMm-8试验，这些试验满足了主要终点，进展性生存期有统计学上的显著改善。DREAMm-7还显示出明显的整体生存获益。安全性特征与已知个体药物特征一致。这标志着2024年Blenrep联合治疗第六次主要监管申请被接受，包括欧盟、日本、英国、加拿大和瑞士。多发性骨髓瘤是全球第三大常见血癌，仍然是一个重要的健康问题，预计在2024年美国将有超过35,000个新病例。如果获批，Blenrep联合疗法可能会重新定义首次复发时或之后的治疗，为患者提供新的选择，副作用可控且可以在社区进行管理。
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