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# Panel Votes Down GSK Multiple Myeloma Drug
- URL: https://www.fdaweb.com/panel-votes-down-gsk-multiple-myeloma-drug/
- Published: 2025-07-17T12:00:00.000Z
- Updated: 2026-09-14T15:16:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159527

FDA’s Oncologic Drugs Advisory Committee 7/17 voted against approving GSK’s BLA for Blenrep (belantamab mafodotin) for treating adults with multiple myeloma in combination with other therapies in patients who have received at least one prior line of therapy. Panel members voted five to three against the risk-benefit profile on the proposed dosage of Blenrep in combination with bortezomib (Velcade) and dexamethasone; and seven to one against the risk-benefit profile on the proposed dosage of Blenrep in combination with pomalidomide (Pomalyst) and dexamethasone.

Panel members seemed to track concerns raised in an FDA [briefing document](https://www.fda.gov/media/187578/download?ref=fdaweb.com) that highlighted a persistent and troubling safety signal — ocular toxicity. Despite new data showing that belantamab mafodotin, when combined with standard therapies, significantly improved progression-free survival compared to comparator regimens, panelists were significantly concerned that large numbers of patients in the belantamab-containing arms experienced Grade 3 or 4 eye-related adverse events, including keratopathy, vision changes, dry eyes, and photophobia.

Blenrep was originally granted accelerated approval in 2020 for heavily pretreated multiple myeloma patients. In 2022, its approval was withdrawn after the DREAMM-3 trial, designed to confirm the drug’s benefit, did not demonstrate superiority over standard treatment. An FDA decision on the drug’s approval and possible reintroduction in the U.S. is expected by 7/23.