2022-22616: Tissue Agnostic Drug Development in Oncology; Draft Guidance for Industry; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Tissue Agnostic Drug Development in Oncology." For the purpose of this guidance, the term "tissue agnostic oncology drug" refers to a drug that targets a specific molecular alteration(s) (a kind of biomarker) across multiple cancer types as defined, for example by organ, tissue, or tumor type. This draft guidance describes the development of tissue agnostic drugs, scientific considerations in determining when tissue agnostic oncology drug development may be appropriate, and, if appropriate, issues to be addressed during such development. Tissue agnostic drug development may expedite or enable the development of new therapies for patients with rare cancer types.
The agency’s own summary, as published.
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