FDA

Blenrep approved (again) for relapsed/refractory multiple myeloma

October 24, 2025

On October 23, 2025, FDA approved Blenrep (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’ve received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.

Blenrep received accelerated FDA approval in 2020 for heavily pretreated multiple myeloma based on early response data. However, the drug was voluntarily withdrawn from the U.S. market in 2022 after a confirmatory trial failed to demonstrate a survival benefit.

Efficacy

Efficacy was evaluated in DREAMM-7 (NCT04246047), an open-label, randomized, multicenter trial in adults with relapsed or refractory multiple myeloma who’d 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 randomized (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’d 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% 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). 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).

Safety

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.

Recommended dose

The recommended dosage of belantamab mafodotin-blmf 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.

Sources:

FDA approves belantamab mafodotin-blmf for relapsed or refractory multiple myeloma. [News release]. 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma

Blenrep approved by US FDA for use in treatment of relapsed/refractory multiple myeloma. [News release]. 2025. https://www.gsk.com/en-gb/media/press-releases/blenrep-approved-by-us-fda-for-use-in-treatment-of-relapsedrefractory-multiple-myeloma/

Blenrep (belantamab mafodotin-blmf) [package insert]. GSK. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Blenrep/pdf/BLENREP-PI-MG.PDF Revised October 2025. Accessed October 24, 2025.