Summit Therapeutics, which manages the drug's development outside of China, announced the agency's decision on Sunday following a formal agency letter. FDA reviewers concluded that the medication could not be cleared because it lacked an overall survival benefit for patients. Even though the therapy successfully slowed the progression of lung cancer, this was not enough to satisfy safety and efficacy standards. The regulatory setback was not entirely unforeseen for the involved drugmakers.
Key points
Regulators require an overall survival benefit to establish an acceptable benefit-risk pr…: Regulators require an overall survival benefit to establish an acceptable benefit-risk profile for this lung cancer therapy.
The agency's rejection blocks the drugmaker from advancing the treatment outside of China…: The agency's rejection blocks the drugmaker from advancing the treatment outside of China at this time.
Industry observers and developers did not view the adverse regulatory determination as an…: Industry observers and developers did not view the adverse regulatory determination as an entirely unforeseen event.
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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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