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2022-10-18| Policy

FDA Drops New Oncology Development Guidelines

by Reed Slater
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The FDA released a trio of documents covering tissue-agnostic development, adverse reactions caused by immunotherapies, and acute myeloid leukemia (AML) development guidelines to maintain high drug development standards. The first two documents are additional drafts, revising content from years prior, and the AML development document is a final version, though all three include nonbinding recommendations. 
Tissue-Agnostic Drug Development in Oncology

Instead of targeting a specific cancer type isolated in a certain tissue or organ, tissue-agnostic therapies can target mutation alterations across multiple cancer types. Tissue-agnostic cancer drugs have the potential to be more flexible for patient needs and open the opportunity to address several cancer types as opposed to just one.

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