Ahead of an advisory committee meeting, FDA reviewers highlighted significant safety issues with GSK’s Blenrep in multiple myeloma treatment, especially high rates of severe ocular toxicities including keratopathy and vision loss. Despite efficacy demonstrated in trials, unanswered questions about dosing and ocular risk profiles remain. The drug’s approval was withdrawn in 2023 after confirmatory trials failed to meet endpoints, but GSK is seeking approval for reintroduction with combination therapies, contending with regulatory scrutiny over its benefit-risk balance.