Ocular toxicity assessment stands between multiple myeloma patients and the first BCMA approval

FDA’s regulatory decision on the first BCMA-targeted therapy will come down to whether its benefits in multiple myeloma outweigh an ocular toxicity that FDA has tolerated in the past, but at a lower incidence rate.

Briefing documents released ahead of the July 14 Oncologic Drugs Advisory Committee (ODAC) meeting for belantamab mafodotin, a BCMA-targeted antibody-drug conjugate from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), raised concerns about keratopathy that led to severe vision loss in some patients in a pivotal Phase II trial. ...