Evaluating Cancer Drugs in Patients With Central Nervous System Metastases; Guidance for Industry; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Evaluating Cancer Drugs in Patients with Central Nervous System Metastases; Guidance for Industry." The guidance document provides recommendations regarding the design of clinical trials of drugs and biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (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 guidance includes study design recommendations regarding the patient population, available therapy, prior therapies, assessment of CNS disease, study endpoints, and leptomeningeal disease. The guidance announced in this notice finalizes the draft guidance of the same title dated August 2020.