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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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.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-2025-D-1071
- Docket Number:
- FDA-2025-D-1071
- Issued by:
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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.
