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Investing.com -- GSK Plc (NYSE:GSK) stock fell 5% after a U.S. Food and Drug Administration advisory panel voted against recommending approval for its blood cancer drug Blenrep, citing concerns that risks outweigh benefits.
The FDA’s Oncologic Drugs Advisory Committee voted 5-to-3 against the combination of Blenrep with the generic cancer drug Velcade, and delivered an even stronger 7-to-1 rejection against pairing it with Bristol Myers Squibb Co.’s (NYSE:BMY) Pomalyst.
While the panel’s recommendation is non-binding, it significantly influences the FDA’s final decision, which is expected by July 23. The committee’s concerns centered around Blenrep’s potential to cause eye damage, with questions remaining about whether a lower dose might reduce this risk.
The rejection represents a setback for GSK’s efforts to reintroduce Blenrep to the U.S. market. The drug was previously withdrawn in both the U.S. and Europe after failing to demonstrate superiority over existing treatments for a different patient group.