Biopharmaceutical company GSK plc (LSE: GSK) (NYSE: GSK) announced on Monday that the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for its Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex) and pomalidomide plus dexamethasone (PomDex) for relapsed or refractory multiple myeloma. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of 23 July 2025.

The submission is based on data from the Phase III DREAMM-7 and DREAMM-8 trials, which demonstrated significant efficacy for the Blenrep combinations. DREAMM-7 showed a clinically meaningful overall survival (OS) benefit, while both trials met their primary endpoint of progression-free survival (PFS), with improvements in secondary endpoints, including deeper and more durable responses compared to standard care.

This filing marks the sixth major regulatory submission for Blenrep combinations in 2024. Previous submissions for the same indication have been accepted in the EU, UK, Japan (with priority review), Canada and Switzerland. In China, Blenrep has received Breakthrough Therapy Designation.

Multiple myeloma, a blood cancer that is difficult to treat once it becomes refractory, has a high unmet need for new therapies. GSK's ongoing research into Blenrep combinations aims to provide new treatment options for patients with relapsed or refractory disease.