The Food and Drug Administration rejected a treatment for a type of lung cancer developed by the U.S.-based biotech Summit Therapeutics and the Chinese drugmaker Akeso, Summit said on Sunday.
In a letter sent to the companies, FDA regulators said the drug, called ivonescimab, could not be approved because it didn’t help patients live longer. While the drug was found to slow lung cancer worsening in patients, the absence of a survival benefit “does not support the positive benefit-risk profile in support of approval,” FDA reviewers concluded.
The FDA’s rejection of ivonescimab is a regulatory setback for Summit, which oversees development of the drug outside of China, although one that was not entirely unforeseen.
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