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GUIDANCE DOCUMENT

Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings Guidance for Industry July 2022

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2020-D-1802
Issued by:
Guidance Issuing Office
Oncology Center of Excellence
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

This guidance provides recommendations to clinical investigators and sponsors regarding the inclusion of patients who have not received available therapy (commonly referred to as existing treatment options) for their cancer in clinical trials of drugs and biological products for the treatment of cancer in the non-curative setting (i.e., when there is no potential for cure or prolonged/near normal survival). For the purpose of this guidance, non-curative is generally defined as 1) unresectable, locally advanced, or metastatic disease in solid tumors or 2) hematologic malignancies with unfavorable long-term overall survival.

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All written comments should be identified with this document's docket number: FDA-2020-D-1802.

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