Blenrep approved by US FDA for use in treatment of relapsed/refractory multiple myeloma

CAR-T Digest - August 2020

23 October 2025: Blenrep approved by US FDA for use in treatment of relapsed/refractory multiple myeloma

The US FDA has approved Blenrep (Belantamab mafodotin) in combination with bortezomib and dexamethasone (BVd) for adults with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent
The approval is based on results from the DREAMM-7 Phase 3 trial, which showed a 51% reduction in risk of death and tripled median progression-free survival (31.3 vs 10.4 months) compared to a daratumumab-based triplet, with a consistent safety profile
Blenrep is the only anti-BCMA therapy available in community settings, where 70% of patients receive care, supported by a new streamlined REMS program designed to simplify safety monitoring and reduce administrative burden
GSK is expanding the DREAMM clinical program to evaluate Blenrep in earlier lines of treatment, including newly diagnosed patients, with multiple Phase 3 studies ongoing and overall survival data expected in 2028
The combination therapy is already approved in several international markets (EU, UK, Japan, Canada, Switzerland, Brazil), with applications under review globally, including in China under breakthrough therapy and priority review designations.