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# Guidances on Adjuvant Treatments for Renal, Bladder Cancer
- URL: https://www.fdaweb.com/guidances-on-adjuvant-treatments-for-renal-bladder-cancer/
- Published: 2020-10-01T12:00:00.000Z
- Updated: 2026-09-14T16:31:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147780

FDA has published two guidances with recommendations for sponsors on developing drugs and biologics for the adjuvant treatment of renal cell carcinoma and muscle-invasive bladder cancer. Each document has recommendations about eligibility criteria, choice of comparator, follow-up imaging assessments, determination of disease recurrence, analyses of disease-free survival, and interpretation of trial results. In each instance, the agency says that while it may consider endpoints other than disease-free survival for the adjuvant treatment of the two types of cancers, the guidances are focused on clinical trials with disease-free survival as the primary endpoint.

Download the renal cell carcinoma guidance [here](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/renal-cell-carcinoma-developing-drugs-and-biologics-adjuvant-treatment?ref=fdaweb.com) and the bladder cancer guidance [here](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bladder-cancer-developing-drugs-and-biologics-adjuvant-treatment?ref=fdaweb.com).