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# Brain Metastases Patients in Cancer Trials
- URL: https://www.fdaweb.com/brain-metastases-patients-in-cancer-trials/
- Published: 2020-07-13T12:00:00.000Z
- Updated: 2026-09-14T16:20:50.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147176

*Federal Register* notice: FDA has made available a final guidance entitled “Cancer Clinical Trial Eligibility Criteria: Brain Metastases.” The document encourages designing clinical trials that include such patients and including this information in the labeling. “Evidence of clinical efficacy in the subset of patients with brain metastases compared to available therapy, with similar efficacy in patients without brain metastases, could serve as the basis for one or more expedited programs (i.e., fast track designation, breakthrough therapy designation, priority review designation, and/or accelerated approval),” it says. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-07-13/pdf/2020-14997.pdf?ref=fdaweb.com).