GSK’s antibody-drug conjugate Blenrep faced setbacks as the FDA’s Oncologic Drugs Advisory Committee voted against its relapsed multiple myeloma label expansion. Concerns raised include significant ocular toxicities such as keratopathy and corneal ulcers, high dose modification rates, and low U.S. patient enrollment in pivotal DREAMM-7 and -8 trials. The advisory committee questioned the benefit-risk profile at proposed dosages, with strong efficacy data overshadowed by safety worries. These obstacles cloud Blenrep’s path to U.S. market return after its 2022 withdrawal post-phase III failure.