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# Guide to Characterize Combination Cancer Drugs
- URL: https://www.fdaweb.com/guide-to-characterize-combination-cancer-drugs/
- Published: 2025-07-16T12:00:00.000Z
- Updated: 2026-09-14T15:16:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159516

FDA has published a draft guidance, *Development of Cancer Drugs for Use in Novel Combination—Determining the Contribution of the Individual Drugs’ Effects*, with recommendations for characterizing the safety and effectiveness of individual drugs for use in a novel combination regimen in treating cancer. The [document](https://www.fda.gov/media/187589/download?ref=fdaweb.com) says the guidance is intended for sponsors developing drugs for use in combination to treat cancer.

The guidance reflects FDA’s current thinking about the use of clinical data to demonstrate the contribution of effect for these types of oncology novel combinations:

- two or more investigational drugs that have not been previously approved by FDA for any indication;
- an investigational drug with a drug approved for a different indication; and
- two or more drugs approved for different indications.

The guidance does not address the contribution of effect in settings where an investigational drug is being developed in combination with a drug approved for the same indication for the purpose of comparing the approved drug to the combination or to fixed combinations of previously approved drugs for the approved indications. It also does not address safety or dosing considerations when designing trials to study two or more drugs when used in combination. Finally, FDA says, it does not address the evaluation of safety data to support the benefit/risk of two or more drugs when used in combination.