In a surprise, advisers to the Food and Drug Administration on Thursday voted that the risks tied to a blood cancer drug from GSK outweighed the benefits it had demonstrated in trials, as concerns about sometimes serious eye-related side effects and questions about the dose the company selected dominated a hearing.
The FDA is set to decide whether to approve the drug, called Blenrep, by as soon as next week. The agency often follows its advisers’ recommendations, but does not have to.
In briefing documents released earlier this week, agency staff highlighted their concerns about the ocular issues and suggested that lower dosages of Blenrep could offer patients similar efficacy in treating multiple myeloma while lowering the risk of side effects.
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