FDA Advisory Committee Votes Against GSK’s Blenrep in Multiple Myeloma

On July 17, 2025, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted against the approval of GSK’s Blenrep (belantamab mafodotin-blmf) combinations for patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.234

The committee voted 5-3 against the Blenrep combination with bortezomib (Velcade) and dexamethasone, and 7-1 against the combination with pomalidomide (Pomalyst) and dexamethasone, citing concerns about the proposed dosage and the overall benefit/risk profile.3

Advisers raised significant concerns around serious eye-related side effects, including a high incidence of keratopathy, visual acuity events, and cases of corneal ulcers observed in clinical trials.14

Other issues included the high rate of dose modifications required in trials and questions about whether the dosage evaluated was appropriate.14

Another point of discussion was the lack of U.S. patients enrolled in the pivotal DREAMM-7 and -8 clinical trials, limiting assessment of benefit-risk for the U.S. population.3

While Blenrep combinations are already approved for multiple myeloma in the UK, Japan, and several other countries, the FDA’s final decision is pending and expected by July 23, 2025.2

GSK has stated it remains confident in Blenrep’s benefit/risk profile and will continue working with the FDA during the ongoing review.2

Sources:

1. https://www.statnews.com/2025/07/17/blenrep-advisory-committee-fda-gsk-multiple-myeloma/

2. https://www.gsk.com/en-gb/media/press-releases/gsk-provides-update-on-us-fda-advisory-committee-review-of-blenrep-belantamab-mafodotin-blmf-combinations-for-patients-with-relapsedrefractory-multiple-myeloma/

3. https://www.cancernetwork.com/view/odac-votes-against-2-belantamab-mafodotin-combinations-in-multiple-myeloma

4. https://www.fiercepharma.com/pharma/fda-advisors-spurn-gsks-blenrep-comeback-dreams-safety-trial-concerns