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Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics Guidance for Industry December 2018

Final Level 2 Revised Guidance
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
Oncology Center of Excellence

This guidance provides recommendations to applicants on endpoints for cancer clinical trials submitted to the Food and Drug Administration (FDA) to support effectiveness claims in new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications.   It also provides background information and discusses general regulatory principles.  The endpoints discussed in this guidance are for drugs to treat patients with an existing cancer.   This guidance does not address endpoints for drugs to prevent or decrease the incidence of cancer.

This guidance is a revision of the final guidance of the same title that published in May 2007.  This guidance replaces the May 2007 guidance of the same title.  

In general, FDA’s guidance documents do not establish legally enforceable responsibilities.  Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.