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# Non-Curative Setting Available Therapy
- URL: https://www.fdaweb.com/non-curative-setting-available-therapy/
- Published: 2022-07-27T12:00:00.000Z
- Updated: 2026-09-14T17:53:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152383

FDA has published a [guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cancer-clinical-trial-eligibility-criteria-available-therapy-non-curative-settings?ref=fdaweb.com), *Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings*, with recommendations for clinical investigators and sponsors about including patients who have not received available therapy for their cancer in clinical trials of drugs and biological products for the treatment of cancer in the non-curative setting. The document says that for the purposes of the guidance, non-curative is defined as **(1)** unresectable, locally advanced, or metastatic disease in solid tumors or **(2)** hematologic malignancies with unfavorable long-term overall survival.