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

Regulatory approval

On October 23, 2025, the FDA approved belantamab mafodotin-blmf (Blenrep; GlaxoSmithKline), a BCMA-directed antibody–drug conjugate (microtubule inhibitor conjugate), with bortezomib and dexamethasone for adults with relapsed or refractory multiple myeloma who have received ≥2 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.

Key efficacy evidence (DREAMM-7; NCT04246047)

Approval was supported by DREAMM-7, an open-label, randomized, multicenter trial. Patients were randomized 1:1 to BVd (belantamab mafodotin-blmf + bortezomib + dexamethasone) or DVd (daratumumab + bortezomib + dexamethasone). The efficacy population included 217 patients who had received ≥2 prior lines.

Endpoints included PFS and OS:

• Median PFS: 31.3 months (95% CI 23.5–NR) with BVd vs 10.4 months (95% CI 7–13.4) with DVd; HR 0.31 (95% CI 0.21–0.47)
• Median OS: NR with BVd vs 35.7 months (95% CI 21.1–NR) with DVd; HR 0.49 (95% CI 0.32–0.76)

Key exclusions included prior BCMA-directed therapy and certain corneal disease.

Safety and access

Prescribing information includes a Boxed Warning for ocular toxicity. In DREAMM-7, ocular toxicity occurred in 92% (Grade 3/4 77%); 83% required dosage modification. Due to ocular risk, belantamab mafodotin-blmf is available only through the BLENREP REMS. Additional warnings include thrombocytopenia and embryo-fetal toxicity.

Dosing (per label)

Belantamab mafodotin-blmf 2.5 mg/kg every 3 weeks with bortezomib/dexamethasone for 8 cycles, then 2.5 mg/kg every 3 weeks as monotherapy until progression or unacceptable toxicity.