FDA has released a new draft guidance on "Development of Cancer Drugs for Use in Novel Combination – Determining the Contribution of the Individual Drugs' Effects" for public comments. If you are interested in commenting, responses are due by15Sep25.
This draft guidance is designed to cover several situations where two or more drugs are being evaluated in combination for the treatment of cancers.
- · "Two (or more) investigational drugs that have not been previously approved by FDA for any indication
- · An investigational drug with a drug(s) approved for a different indication
- · Two (or more) drugs approved for a different indication(s)"
In contrast there are two situations that the guidance was not written to cover:
1. "This guidance does not address contribution of effect in settings where an investigational drug is being developed in combination with a drug approved for the same indication for the purposes of comparing the approved drug to the combination (i.e., "add-on" trials to standard of care (SOC)) or to fixed combinations of previously approved drugs for the approved indication(s).
2. In addition, this guidance does not address safety or dosing considerations when designing trials to study two or more drugs when used in combination. Nor does it address the evaluation of safety data to support the benefit-risk of two or more drugs when used in combination."
https://www.fda.gov/media/187589/download
#fda #NovelCombinationDrugs
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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