On October 23, 2025, the FDA approved belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline), a targeted B-cell maturation antigen (BCMA) antibody-drug conjugate, 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 efficacy of belantamab mafodotin-blmf was evaluated in the DREAMM-7 (NCT04246047) open-label, randomized, multicenter trial in adults with relapsed or refractory multiple myeloma who had received at least one prior therapy. Patients’ refractory or intolerant to daratumumab or bortezomib, previously treated with BCMA-directed therapy, or with significant corneal disease were excluded.

Participants were randomized 1:1 to receive belantamab mafodotin-blmf with bortezomib and dexamethasone (BVd) or daratumumab with bortezomib and dexamethasone (DVd). The efficacy population included 217 patients who had received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.

Efficacy was established based on progression-free survival (PFS) and overall survival (OS). Median PFS was 31.3 months (95% CI: 23.5–NR) in the BVd arm versus 10.4 months (95% CI: 7–13.4) in the DVd arm (HR 0.31; 95% CI: 0.21–0.47). Median OS was not reached for BVd and 35.7 months (95% CI: 21.1–NR) for DVd (HR 0.49; 95% CI: 0.32–0.76).

The treatment carries a boxed warning for ocular toxicity, including changes in the corneal epithelium, vision deterioration, and frequent dosage modifications due to these effects. Additional warnings include thrombocytopenia and embryo-fetal toxicity. Due to ocular risks, the therapy is available only through a restricted Risk Evaluation and Mitigation Strategy (REMS) program.

Recommended dose is 2.5 mg/kg IV every three weeks in combination for eight cycles, then as a single agent until progression or unacceptable toxicity.

Learn more: FDA approves belantamab mafodotin-blmf for relapsed or refractory multiple myeloma