Date of Action: October 23, 2025
Entity: GlaxoSmithKline (GSK)
Drug: Belantamab mafodotin (Blenrep)
Advisory Committee: Oncologic Drugs Advisory Committee (ODAC)
Vote Count (July 2025): 7-1 Against (BPd regimen); 5-3 Against (BVd regimen)
The resurrection of Blenrep (belantamab mafodotin) in October 2025 stands as a defining case study in the FDA’s modern regulatory calculus, where statistical hazard ratios for efficacy are permitted to override profound safety signals and decisive advisory committee rejections. GSK successfully returned its BCMA-targeting antibody-drug conjugate (ADC) to the U.S. market three years after a humiliating withdrawal, securing a broad approval that blatantly contradicts the formal recommendation of the agency’s own external experts.
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