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FDA approves belantamab mafodotin in combination with bortezomib and dexamethasone for R/R multiple myeloma

On October 23, 2025, the U.S. Food and Drug Administration (FDA) approved belantamab mafodotin, a BCMA-directed antibody and microtubule inhibitor conjugate, in combination with bortezomib and dexamethasone (BVd) for adult patients with relapsed/refractory (R/R) multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD).

Multiple myeloma remains the second most common hematologic malignancy, and despite several therapeutic advances, most patients ultimately experience relapse and require subsequent lines of therapy.2

The approval was supported by data from the open-label, randomized, multicenter Phase III DREAMM-7 trial (NCT04246047), which evaluated BVd versus daratumumab, bortezomib, and dexamethasone (DVd) in 217 patients who had received at least two prior lines of therapy, including a PI and an IMiD. Median progression-free survival was 31.3 months (95% CI: 23.5, not reached) in the BVd arm compared with 10.4 months (95% CI: 7.0, 13.4) in the DVd arm (hazard ratio [HR], 0.31; 95% CI: 0.21–0.47). Median overall survival was not reached in the BVd arm, and was 35.7 months (95% CI: 21.1, NR) in the DVd arm.

In DREAMM-7, ocular toxicity occurred in 92% of patients receiving BVd, with Grade 3/4 events in 77%, and 83% requiring dose modification.1 Due to this risk, the agent is available only through the BLENREP REMS program. Additional toxicities include thrombocytopenia and embryo-fetal toxicity. We recently spoke with Meral Beksac, MD, Istinye University Ankara Liv Hospital, Ankara, Turkey, who shared guidance on managing ocular toxicities associated with belantamab mafodotin in multiple myeloma.

This approval introduces a new BCMA-directed treatment option for patients with R/R multiple myeloma after at least two prior lines of therapy, expanding available therapeutic choices in this difficult-to-treat population.

References

  1. U.S. Food and Drug Administration. FDA approves belantamab mafodotin-blmf for relapsed or refractory multiple myeloma. Available here. (Last accessed 23/10/2025).
  2. van de Donk NWCJ, Pawlyn C, Yong KL. Multiple myeloma. Lancet. 2021 Jan 30;397(10272):410-427.

Written by Anya Dragojlovic Kerkache

Reviewed by Ellen Jackson