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GUIDANCE DOCUMENT

Development of Cancer Drugs for Use in Novel Combination - Determining the Contribution of the Individual Drugs’ Effects Draft Guidance for Industry July 2025

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2025-D-1071
Issued by:
Guidance Issuing Office
Oncology Center of Excellence

This guidance provides recommendations for characterizing the safety and effectiveness of individual drugs used in novel combination regimens for treating cancer, with a focus on demonstrating the "contribution of effect" – how each drug contributes to the overall treatment benefit observed in patients. The guidance is intended for sponsors developing cancer drug combinations and addresses three specific scenarios: (1) Two (or more) investigational drugs that have not been previously approved by FDA for any indication, (2) An investigational drug with a drug(s) approved for a different indication, and (3) Two (or more) drugs approved for a different indication(s). The recommendations are designed to be consistent with existing FDA regulations for fixed-combination prescription drugs and expand upon the 2013 guidance for industry Codevelopment of Two or More New Investigational Drugs for Use in Combination. The guidance does not cover situations where an investigational drug is being developed in combination with a drug approved for the same indication for purposes of comparing the approved drug to the combination (i.e., "add-on" trials to standard of care), fixed combinations of previously approved drugs for the approved indications, safety or dosing considerations when designing combination trials, or the evaluation of safety data to support the benefit-risk assessment of combination therapies.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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-2025-D-1071.

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