Summary by Moomoo AI
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.
