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# FDA Finalizes Cancer Trial Endpoints Guidance
- URL: https://www.fdaweb.com/fda-finalizes-cancer-trial-endpoints-guidance/
- Published: 2019-01-02T12:00:00.000Z
- Updated: 2026-09-15T00:51:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143060

FDA has published a finalized guidance, *Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics*, that revises and replaces a 5/2007 draft guidance. The [document](https://www.fda.gov/downloads/drugs/GuidanceComplianceRegulatoyInformation/Guidance/UCM071590.pdf?utm%5Fcampaign=FDA%20releases%20Guidance%20for%20Industry%20on%20Clinical%20Trial%20Endpoints%20for%20the%20Approval%20of%20Cancer%20Drugs&utm%5Fmedium=email&utm%5Fsource=Eloqua) gives recommendations to applicants on endpoints for cancer clinical trials submitted to FDA to support effectiveness claims in NDAs, BLAs, or supplements. It says the endpoints discussed are for drugs to treat patients with existing cancer. The draft does not address endpoints for drugs to prevent or decrease the incidence of cancer.

Covered in the guidance are Introduction, Background, General Endpoint Considerations, Clinical Trial Design and Analysis Considerations, Conclusion, and an Appendix on Independent Review of Tumor Endpoints.