Belantamab mafodotin

GSK’s Blenrep, withdrawn in 2022, seeks FDA approval in combination with Velcade/dexamethasone or Pomalyst/dexamethasone for multiple myeloma patients with prior therapy. Based on DREAMM-7 and DREAMM-8 trials, Blenrep combos showed significant PFS improvements over standard-of-care, with manageable safety profiles. Expected to compete with BCMA CAR-T therapies like Carvykti and Tecvayli, Blenrep could offer simpler IV infusion benefits.

GSK's Blenrep combinations for relapsed and refractory multiple myeloma accepted by the US FDA, with a decision expected by July 23. The application covers Blenrep with BorDex and PomDex for patients who have undergone at least one prior therapy.

GSK's BLA for Blenrep in combinations with bortezomib plus dexamethasone (BVd) and pomalidomide plus dexamethasone (BPd) for multiple myeloma treatment accepted by FDA, with action date of 23 July 2025. Based on DREAMM-7 and DREAMM-8 trials, showing significant PFS improvements.

GSK's Blenrep (belantamab mafodotin) combinations with BorDex (BVd) and PomDex (BPd) for multiple myeloma treatment, supported by DREAMM-7 and DREAMM-8 trials, submitted for FDA review with an action date of 23 July 2025. DREAMM-7 showed statistically significant overall survival benefits.

USFDA accepts Blenrep combinations for review in treating relapsed/refractory multiple myeloma, potentially transforming treatment options with manageable side effects.

Blenrep (belantamab mafodotin) plus bortezomib and dexamethasone (BorDex) significantly reduced the risk of death in the DREAMM-7 phase III trial for relapsed/refractory multiple myeloma compared to daratumumab plus BorDex, showing a statistically significant and clinically meaningful overall survival benefit.

GSK announces positive results from DREAMM-7 trial showing Blenrep plus BorDex significantly reduces death risk in relapsed/refractory multiple myeloma compared to daratumumab plus BorDex, with full data to be presented at 2024 ASH Annual Meeting.

GSK's Phase III DREAMM-7 trial for Blenrep (belantamab mafodotin) with bortezomib and dexamethasone in relapsed or refractory multiple myeloma met its key secondary endpoint of overall survival, indicating a significant reduction in the risk of death compared to standard care. The company plans to initiate a Phase III study for newly diagnosed multiple myeloma patients not eligible for transplant by late 2024.

GSK's DREAMM-7 trial showed belantamab mafodotin + BorDex significantly reduced death risk vs. daratumumab + BorDex in relapsed/refractory multiple myeloma, meeting OS secondary endpoint. Full results to be presented at ASH 2024.