Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings; Guidance for Industry; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings." The guidance provides recommendations to sponsors of clinical trials of investigational cancer drugs regarding the inclusion of patients who have not previously received available therapy (commonly referred to as existing treatment options) for their cancer in the non-curative setting. This guidance finalizes the draft guidance of the same title issued on June 24, 2021.