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GUIDANCE DOCUMENT

Evaluating Cancer Drugs in Patients with Central Nervous System Metastases Draft Guidance for Industry August 2020

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Submit Comments by

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-0938


Docket Number:
FDA-2020-D-0938
Issued by:
Guidance Issuing Office
Oncology Center of Excellence
Center for Drug Evaluation and Research
Office of the Commissioner

The purpose of this guidance is to describe FDA’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.

FDA’s current thinking regarding inclusion of patients with brain metastases in clinical trials is addressed in the guidance for industry Cancer Clinical Trial Eligibility Criteria: Brain Metastases.

Questions?

Contact Point
Human Drug Information
Office of Communications
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Hillandale Building, 4th Fl
Silver Spring, MD 20993
druginfo@fda.hhs.gov
(855) 543-3784 Toll Free
(301) 796-3400
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010
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