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USFDA Guidance: Multiple Guidances related to Oncology

USFDA's Oncology Center of Excellence released multiple guidances related to Oncology earlier today (17-Oct-2022).

In this draft guidance, recommendations are made regarding the data that must be collected and evaluated in order to assess whether adverse events are immune-mediated adverse reactions (imAR) and what data should be included in a new drug application (NDA) or biologics license application (BLA) for a cancer immunotherapeutic drug. Examples of such cancer immunotherapeutic drugs include monoclonal antibodies, anticancer vaccines, and cytokines.

The purpose of this final guidance is to assist sponsors in the clinical development of drugs and biological products for the treatment of acute myeloid leukemia (AML). This guidance focuses specifically on how drugs should be developed to support the treatment of AML, including indications limited to a single phase of treatment (i.e., maintenance, transplantation preparatory regimen, etc.) and how clinical trial designs should be designed.

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. The purpose of this draft guidance is to provide information about the development of tissue-agnostic drugs, the scientific considerations for determining when such development might be appropriate, and the issues that should be addressed during such development, if appropriate.


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