FDA rejects Summit Therapeutics and Akeso lung cancer drug ivonescimab over lack of survival benefit
Summit Therapeutics said Sunday that the U.S. Food and Drug Administration had rejected ivonescimab, a lung cancer medicine the American biotech is developing with Chinese drugmaker Akeso. In a letter to the companies, FDA reviewers concluded the drug could not be approved because it did not help patients live longer. Trial evidence showed ivonescimab slowed worsening of the disease, but regulators judged that the lack of an overall survival benefit “does not support the positive benefit-risk profile in support of approval.”
The decision is a regulatory setback for Summit, which oversees development of the treatment outside China. The company indicated the outcome was not entirely unforeseen. For patients and investors following the program, the core issue is not whether the drug delayed progression, but whether that delay, without a demonstrated gain in how long people live, is enough for U.S. marketing authorization. On the FDA’s reading, it is not.
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