FDA Advisory Committee Voices Concern Over GSK's Blenrep for Multiple Myeloma

The FDA's Oncologic Drugs Advisory Committee voted against GlaxoSmithKline's Blenrep for multiple myeloma, citing unfavorable benefit-risk considerations. High rates of ocular toxicities including keratopathy and vision loss were major concerns, compounded by limited dose optimization. Though Blenrep showed efficacy in combination regimens and some trials met endpoints, the advisory panel emphasized uncertain safety and data limitations. The FDA briefing document underscores the regulatory challenge GSK faces in reintroducing Blenrep to the U.S. market following its prior withdrawal.