The FDA has approved Blenrep (belantamab mafodotin-blmf) in combination with bortezomib and dexamethasone (BVd) for adults with relapsed or refractory multiple myeloma (RRMM) who have received at least two prior lines of therapy including a proteasome inhibitor and an immunomodulatory drug.
Approval Basis – DREAMM-7 Trial (NCT04246047):
The Phase 3, open-label study randomized patients to Blenrep + bortezomib + dexamethasone vs daratumumab + bortezomib + dexamethasone.
Median PFS: 31.3 months (BVd) vs 10.4 months (DVd); HR 0.31. Overall survival: Not reached vs 35.7 months; HR 0.49. These results represent a ~70% reduction in risk of progression and a ~50% reduction in risk of death.
Safety:
The most common adverse events were ocular toxicity, thrombocytopenia, and infusion reactions. Due to the risk of vision changes, Blenrep is available only through a REMS program requiring regular eye exams.
Clinical Impact:
This approval establishes a new BCMA-directed ADC–based option in the RRMM landscape, offering meaningful survival benefit for patients while emphasizing the need for close ocular monitoring.
