FDA accepts for review BLA for Blenerep (belantamab mafodotin) in combinations with bortezomib (BorDex [BVd]) and pomalidomide (PomDex [BPd]) for patients with multiple myeloma
GSK plc announced the FDA has accepted for review a Biologics License Application (BLA) for Blenrep (belantamab mafodotin) in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for the treatment of patients with multiple myeloma who have received at least one prior line of therapy
The US FDA has assigned a Prescription Drug User Fee Act action date of 23 July 2025.
Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “Relapsed/refractory multiple myeloma treatment could be transformed by additional, efficacious treatment options with manageable side effects and community-based administration. The evidence from DREAMM-7 and DREAMM-8 supporting our Blenrep combinations submission has been further strengthened by the statistically significant overall survival results from the DREAMM-7 trial. We look forward to working with the FDA on this review.”
The US application is based on results from the DREAMM-7 and DREAMM-8 phase III trials, which both met their primary endpoints, showing statistically significant and clinically meaningful improvements in progression-free survival (PFS) for the belantamab mafodotin combinations compared to standard of care triplet combinations in relapsed or refractory multiple myeloma.
Results from both trials also showed clinically meaningful improvements across all other secondary efficacy endpoints, including deeper and more durable responses compared to the respective standard of care combinations. The safety and tolerability profiles of the belantamab mafodotin combinations in the DREAMM-7 and DREAMM-8 trials were broadly consistent with the known profiles of the individual agents.
In a subsequent planned interim analysis, the DREAMM-7 trial also met the key secondary endpoint of overall survival (OS), showing a statistically significant and clinically meaningful OS benefit favouring the belantamab mafodotin combination. Efficacy and safety data from this analysis will be presented at the upcoming 66th American Society of Hematology (ASH) Annual Meeting and Exposition on 9 December 2024 at 11:15 a.m. PT. A positive trend in OS was observed in DREAMM-8 but was not statistically significant at the time of interim analysis, and follow-up for OS continues.
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