The U.S. Food and Drug Administration (FDA) advisory committee has recommended against approving GlaxoSmithKline's (GSK, Financial) blood cancer drug, Blenrep (belantamab mafodotin), due to early concerns about eye-related side effects. Following this news, GSK's stock fell over 6%. The British pharmaceutical company is attempting to revive the drug, which was withdrawn from the U.S. market in 2022 after a failed late-stage study.
GSK's resubmission is based on two late-stage trials that showed improved overall survival rates when Blenrep is used in combination with other treatments. This setback comes as GSK focuses on expanding its research and development pipeline to counter declining sales of its top drugs and vaccines. The company's shares dropped as much as 7% to 1,315 pence, making it the biggest loser on the FTSE 100 index, which rose 0.2%.
The FDA is set to make a formal decision on Blenrep soon. Analysts from Berenberg Bank and JPMorgan suggest that the regulatory body is unlikely to approve the drug, as it typically follows the advisory committee's recommendations. GSK remains confident in Blenrep's benefit-risk profile and plans to continue working closely with the FDA. The company forecasts peak annual sales of the drug to exceed £3 billion (approximately $4 billion). The therapy is currently under review in over 10 countries.
