FDA Approves Blenrep for Relapsed or Refractory Multiple Myeloma

THURSDAY, Oct. 30, 2025 (HealthDay News) — The U.S. Food and Drug Administration approved Blenrep (belantamab mafodotin-blmf) in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma. 

The approval is for patients who have received at least two prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory (IMID) agent.

Results from the pivotal DREAMM-7 phase 3 trial informed the approval. In patients who had two or more prior lines of therapy, including a PI and an IMID, compared with a daratumumab-based triplet therapy, Blenrep in combination showed a clinically meaningful reduction in the risk for death (hazard ratio [HR], 0.49) and a tripled median progression-free survival (31.3 months versus 10.4 months; HR, 0.31). No new safety or tolerability signals were seen.

“There is an urgent need for new and novel therapies, as nearly all patients with multiple myeloma experience relapse, and retreating with the same mechanism of action often leads to suboptimal outcomes,” Tony Wood, chief scientific officer at GSK, said in a statement. “As the only anti-B-cell maturation antigen agent that can be administered across health care settings, including in community centers where 70 percent of patients receive care, Blenrep fulfills a major patient need.”

Approval of Blenrep was granted to GSK.

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