Ahead of the July 17 advisory committee meeting, FDA reviewers expressed concerns over GSK's antibody-drug conjugate Blenrep’s ocular toxicity, high rates of dose modifications, and unclear efficacy in multiple myeloma. Despite prior accelerated approval and promising combination therapy data, reviewers doubt the benefit-risk balance and dosage optimization. GSK seeks to regain market approval following withdrawal in 2022 after a failed confirmatory trial, with the PDUFA date set for July 23.