Ahead of an advisory committee meeting, the FDA has flagged significant safety concerns for GSK’s antibody-drug conjugate Blenrep (belantamab mafodotin), notably high rates of ocular toxicity including keratopathy, corneal ulcers, and vision loss. While earlier trials showed efficacy, the FDA finds the risk-benefit profile unclear due to dose modifications and safety signals. The drug was withdrawn in 2022 after confirmatory trials failed primary endpoints. GSK is seeking approval for combination regimens, but regulators remain cautious pending further data.