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# Guide on Immune-mediated Adverse Reactions
- URL: https://www.fdaweb.com/guide-on-immune-mediated-adverse-reactions/
- Published: 2022-10-17T12:00:00.000Z
- Updated: 2026-09-14T18:03:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152981

FDA has issued a draft guidance entitled “Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials.” The [document](https://www.fda.gov/media/162341/download?ref=fdaweb.com) is intended for sponsors of products that modulate the endogenous immune system and may disrupt immunologic tolerance to normal organs and tissues. These include monoclonal antibodies, anticancer vaccines, and cytokines. “Adoptively transferred cell-based cancer immunotherapeutics that target a tumor-associated antigen (TAA) and directly exert an anticancer effect (e.g., a TAA-directed genetically modified T-cell immunotherapy) are outside the scope of this guidance, the agency says.

The draft provides recommendations about the data that should be collected and evaluated to assess whether adverse events qualify as immune-mediated adverse reactions (imARs) and the data on imARs that should be included in NDAs and BLAs. Potential imARs should be evaluated to “guide patient management and inform the drug labeling or investigator brochure, as applicable,” the document says. “While corticosteroids and other immunosuppressive drugs are regularly used to manage imARs in cancer clinical trials, the absence of a history of immunosuppressive treatment for an adverse reaction does not preclude its characterization as an imAR, especially for low-grade imARs that result in dose interruption,” it says.