FDA Approves GSK’s Blenrep for Multiple Myeloma Treatment, Marking a Market Return
FDA approved Blenrep (belantamab mafodotin-blmf) for relapsed or refractory multiple myeloma on October 23, 2025.
Blenrep is used in combination with bortezomib and dexamethasone for patients who have received at least two prior therapies.
The approval is based on the DREAMM-7 Phase III trial, which showed a clinically meaningful reduction in risk of death and progression-free survival.
GSK withdrew Blenrep from the market in 2022 due to trial failures and safety concerns, but recent data supported its reintroduction.