US FDA Eyes Ocular Risks With GlaxoSmithKline’s Myeloma Drug Belantamab

Heading into an advisory committee review, agency suggests belantamab’s risks of keratopathy and other ocular issues have not been fully characterized and questions whether the proposed mitigation measures, including dosing modifications, are adequate.

close up of band keratopathy during eye examination. in dark room.
US FDA is concerned the risk of keratopathy with belantamab may outweigh the drug's benefits. • Source: Shutterstock

The US Food and Drug Administration is questioning whether ocular toxicity with GlaxoSmithKline plc’s belantamab mafodotin outweighs the drug’s benefits in relapsed/refractory multiple myeloma.

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