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# Draft Guide on Tissue Agnostic Drug Development
- URL: https://www.fdaweb.com/draft-guide-on-tissue-agnostic-drug-development/
- Published: 2022-10-17T12:00:00.000Z
- Updated: 2026-09-14T18:03:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152979

FDA has released a draft guidance entitled “Tissue Agnostic Drug Development in Oncology.” The [document](https://www.fda.gov/media/162346/download?ref=fdaweb.com) provides recommendations to sponsors on considerations for tissue agnostic drug development.

The guidance says a “tissue agnostic” oncology drug “targets a specific molecular alteration (a kind of biomarker) across multiple cancer types as defined, for example by organ, tissue, or tumor type. A tissue agnostic oncology drug can therefore be used to treat multiple types of cancer (e.g., colorectal, thyroid, and breast cancers) with the targeted molecular alteration (e.g., either the same targeted molecular alteration or targeted molecular alterations affecting a single pathway).”

FDA says development of a tissue agnostic oncology drug raises issues that generally do not arise in more traditional approaches. The guidance describes the development period, scientific considerations in determining when tissue agnostic oncology drug development may be appropriate, and, if appropriate, issues to be addressed during development. The agency says it does not address the development of drugs intended to prevent or decrease the incidence of cancer and does not address the treatment of cancer in the adjuvant or neoadjuvant setting.

FDA also says a key difference in tissue agnostic oncology drug development is the need to generalize treatment effects based on data observed in some cancer types to other cancer types with the same targeted molecular alteration, particularly when few if any subjects with the other cancer types were included in the clinical trial. It explains that such “generalization may be justified, in appropriate cases, by a strong scientific rationale and clinical circumstances, and may expedite or enable the development of new therapies for patients with rare cancer types when it may not be feasible to test the drug in an adequate number of subjects for every cancer type.”