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Pharmaceuticals / Regulatory Affairs

FDA Lays Out New Guidance on Cancer Endpoints

Dec. 28, 2018

Cancer trials that rely on event-free survival and complete response to treatment as surrogate endpoints will be acceptable to FDA reviewers, the agency said in a new final guidance.

The FDA also is willing to consider emerging endpoints such as symptom improvement or relief, minimal residual disease or metastasis-free survival, the 19-page document states.

The guidance replaces a 2007 document to provide updated thinking on an industry that has evolved rapidly in the past decade or more, the agency said.

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