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# Draft Guide on CNS Cancer Drugs
- URL: https://www.fdaweb.com/draft-guide-on-cns-cancer-drugs/
- Published: 2020-08-27T12:00:00.000Z
- Updated: 2026-09-14T16:26:54.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147526

*Federal Register* notice: FDA has made available a draft guidance entitled *Evaluating Cancer Drugs in Patients with Central Nervous System Metastases*. The document provides recommendations on clinical trial designs for drugs and biological products that are intended to support product labeling describing the antitumor activity in patients with central nervous system (CNS) metastases from solid tumors originating outside the CNS. It includes study design recommendations on patient population, available therapy, prior therapies, assessment of CNS disease, study endpoints, and leptomeningeal disease. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-08-27/pdf/2020-18894.pdf?ref=fdaweb.com).