FDA Approves GSK's Blenrep for Relapsed/Refractory Multiple Myeloma

GSK plc announced that the U.S. Food and Drug Administration (FDA) has approved Blenrep (belantamab mafodotin-blmf) in combination with bortezomib and dexamethasone (BVd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy. The approval is supported by data from the pivotal DREAMM-7 phase III trial, which showed a 51% reduction in the risk of death and a tripled median progression-free survival (PFS) compared to a daratumumab-based triplet. Blenrep is the only anti-BCMA agent accessible in the community setting, where 70% of patients receive care. GSK is advancing the DREAMM clinical program to explore Blenrep's potential in earlier lines of treatment, with data expected in early 2028. The drug is also approved in the European Union, UK, Japan, Canada, Switzerland, and Brazil, with applications under review in other markets globally.