FDA Panel Votes 7-1 and 5-3 Against GSK’s Blenrep Combos; Shares Fall 6.4% Ahead of July 23 PDUFA

A U.S. Food and Drug Administration (FDA) advisory committee voted against the overall benefit-risk profile of GlaxoSmithKline's (GSK) blood cancer drug Blenrep (belantamab mafodotin) in combination therapies for relapsed or refractory multiple myeloma. The panel voted 5-3 against the combination of Blenrep with bortezomib and dexamethasone, and 7-1 against its use with pomalidomide and dexamethasone, concluding that the risks outweighed the benefits at the proposed dosages for the intended patient populations. This negative advisory committee decision casts doubt on the drug's approval prospects in the U.S. market. Following the vote, GSK's shares declined by approximately 6.4%. The FDA's official Prescription Drug User Fee Act (PDUFA) decision date for Blenrep is set for July 23, 2025.