FDA Approves Belantamab Mafodotin-blmf Combination Therapy for Relapsed or Refractory Multiple Myeloma

On October 23, 2025, the FDA approved belanta-mab mafodotin-blmf (Blenrep) in combination with bortezomib and dexamethasone for adult patients with relapsed or refractory multiple myeloma. This approval applies to patients who have received at least 2 prior therapies, including a proteasome inhibitor and an intermodulary agent.¹

The approval was supported by findings from the DREAMM-7 clinical trial (NCT04246047), which demonstrated a median progression-free survival of 31.3 months for patients receiving the combination therapy.

Belantamab mafodotin-blmf is administered intravenously at a dose of 2.5 mg/kg once every 3 weeks in combination with bortezomib and dexamethasone for the first 8 weeks. Belantamab mafodotin-blmf is then given at a dosage of 2.5 mg/kg once every 3 weeks as a single agent until disease progression or unacceptable toxicity.

The prescribing information includes warnings for serious ocular toxicity, which may result in visual changes or other eye-related adverse effects. Patients are required to undergo regular eye examinations before and during treatment.

Reference

1. US Food and Drug Administration. FDA approves belantamab mafodotin-blmf for relapsed or refractory multiple myeloma. October 23, 2025. Accessed November 6, 2025. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma