FDA advisory committee votes against GSK’s Blenrep in multiple myeloma

The FDA’s Oncologic Drugs Advisory Committee voted against endorsing GSK’s Blenrep (belantamab mafodotin) for second-line treatment of multiple myeloma, citing concerns over benefit-risk balance. High rates of ocular toxicity, including severe corneal adverse events and vision decline, compounded by limited dose exploration, underpinned the negative evaluations. Although Blenrep demonstrated efficacy in some trials, the FDA reviewers expressed uncertainty about the broad application of the drug's dosing and associated safety profiles, impacting its potential U.S. market return.