Drugs

Guide on Immune-mediated Adverse Reactions

FDA has issued a draft guidance entitled “Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials.” The document 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.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome