The US Food and Drug Administration has raised safety concerns regarding GSK's antibody-drug conjugate Blenrep (belantamab mafodotin) for multiple myeloma patients, focusing on ocular toxicities and unclear optimal dosing. Despite earlier accelerated approval in 2020, the drug was withdrawn from the US market after confirmatory trial failures. Recent data showed promising efficacy in combination therapies, but the FDA's briefing documents ahead of a July 17 advisory committee meeting highlight high rates of keratopathy and vision acuity events, including severe vision loss and corneal ulcers not seen with other available therapies. The agency questions whether the current evidence supports a favorable benefit-risk profile in the broader US patient population.