FDA Grants Approval to Belantamab Mafodotin for Patients With R/R MM

On October 23, 2025, the US Food and Drug Administration (FDA) approved belantamab mafodotin-blmf, a B-cell maturation antigen (BCMA)-directed antibody and microtubule inhibitor conjugate, with bortezomib and dexamethasone for adults with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least 2 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.

For this approval, efficacy was evaluated in DREAMM-7, an open-label, randomized, multicenter trial in adults with R/R multiple myeloma who had received at least 1 line of prior therapy. It was notable that this trial excluded patients who were refractory or intolerant to daratumumab or bortezomib, had received prior BCMA-directed therapy, and had existing corneal disease, except for mild punctate keratopathy.

Patients were randomized 1 to 1 to receive either belantamab mafodotin-blmf, bortezomib, and dexamethasone (BVd) or daratumumab, bortezomib, and dexamethasone (DVd). The efficacy population included 217 patients, 108 and 109 in each arm, respectively, who had received at least 2 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). The median PFS was 31.3 months (95% confidence interval [CI], 23.5 to not reached [NR]) in the BVd arm and 10.4 months (95% CI, 7 to 13.4) in the DVd arm (hazard ratio [HR] 0.31, 95% CI, 0.2 to 0.47). The median OS was NR and 35.7 months (95% CI, 21.1 ro NR) in respective arms (HR 0.49, 95% CI, 0.32 to 0.76).

Prescribing information includes a Boxed Warning for the risk of ocular toxicity, including corneal epithelium changes resulting in vision deterioration. Among those receiving belantamab mafodotin-blmf in DREAMM-7, ocular toxicity occurred in 92% of patients, including grade 3 or 4 in 77%, with 83% requiring dosage modification due to ocular toxicity. Because of the risk of ocular toxicity, belantamab mafodotin-blmf is available only through a Risk Evaluation and Mitigation Strategy (REMS), called the BLENREP REMS. Other potential adverse event warnings include thrombocytopenia and embryo-fetal toxicity.

Source:

US Food and Drug Administration. Accessed October 23, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma.