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# CNS Cancer Drug Evaluation Guidance
- URL: https://www.fdaweb.com/cns-cancer-drug-evaluation-guidance/
- Published: 2020-08-26T12:00:00.000Z
- Updated: 2026-09-14T16:26:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147518

FDA has issued a draft guidance, *Evaluating Cancer Drugs in Patients with Central Nervous System Metastases*, to give the agency’s recommendations for clinical trial designs of cancer drugs or biological products regulated by CDER and CBER 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. The [document](ttps://www.fda.gov/media/141507/download) says FDA’s current thinking about including patients with brain metastases in clinical trials is addressed in a separate guidance.

The guidance addresses clinical trial design considerations about patient population, available therapy, prior therapies, assessment of CNS metastases, study endpoints, and leptomeningeal disease.