On October 23, 2025, the Food and Drug Administration 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 multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.

Full prescribing information for belantamab mafodotin-blmf will be posted on Drugs@FDA.

Efficacy was evaluated in DREAMM-7 (NCT04246047), an open-label, randomised, multicenter trial in adults with relapsed or refractory multiple myeloma who had received at least one line of prior therapy. The 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 randomised (1:1) 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 respective arms) 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). The median PFS was 31.3 months (95% confidence interval [CI]: 23.5, not reached [NR]) in the BVd arm and 10.4 months (95% CI: 7, 13.4) in the DVd arm (hazard ratio [HR] 0.31, 95% CI: 0.21, 0.47). The median OS was NR and 35.7 months (95% CI: 21.1, NR) in respective arms (HR 0.49, 95% CI: 0.32, 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 Warnings and Precautions include thrombocytopenia and embryo-fetal toxicity.

The recommended belantamab mafodotin-blmf dosage is 2.5 mg/kg once every three weeks in combination with bortezomib and dexamethasone for the first eight cycles, followed by belantamab mafodotin-blmf 2.5 mg/kg once every three weeks as a single agent until disease progression or unacceptable toxicity. Prescribing information contains dosing instructions of the drugs administered in combination with belantamab mafodotin-blmf.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA's assessment.

Belantamab mafodotin-blmf received orphan drug designation.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA's MedWatch Reporting System or by calling 1-800-FDA-1088.

Source: FDA