The FDA’s Oncologic Drugs Advisory Committee voted against the approval of GSK’s antibody-drug conjugate Blenrep (belantamab mafodotin) for relapsed/refractory multiple myeloma in combination regimens due to safety concerns. Committee members highlighted high rates of ocular toxicity, including severe corneal ulcers, and problematic dose modifications in the pivotal DREAMM-7 and -8 trials. Low U.S. patient enrollment in studies and insufficient dosage optimization further influenced the 5-3 and 7-1 negative votes against approval. Despite GSK demonstrating promising efficacy data, the committee deemed the overall benefit-risk unfavorable at proposed dosages.