Drugs

Using ctDNA as an Early Endpoint

A panel at a 7/11 Friends of Cancer Research (FoCR) meeting, “Establishing Evidence: New Advancements Using ctDNA),” discussed regulatory considerations for using circulating tumor DNA (ctDNA) as an early endpoint, including mimicking the process used to establish other novel endpoints to make ctDNA a successful endpoint. A FoCR meeting summary says the panelists, including two from FDA, discussed the importance of identifying the right assays and thresholds to use when analyzing ctDNA and also discussed performance characteristics for assays to ensure the measurement of ctDNA is reliable to support its use as an early endpoint. The group identified key next steps to support the future use of ctDNA, focusing on the need for continued data generation and standardization of ctDNA measurements.

The morning keynote conversation between CDER director Patrizia Cavazzoni and Center for Medicare and Medicaid Services Center for Clinical Standards and Quality director Lee Fleisher discussed interactions between the two agencies relating to making decisions about the approval and coverage of new treatments. They also discussed novel endpoints.

Other conference panels covered (1) evaluating ctDNA measurements across cancer types and stages, and (2) changes in ctDNA levels as an early indicator of outcomes in advanced non-small cell lung cancer treated with tyrosine kinase inhibitors.

The meeting’s lunch keynote featured FDA’s Richard Pazdur, Valerie Jensen, and Harpreet Singh discussing new developments at the agency, including a new pilot program and guidance on oncology drug products used with certain in vitro diagnostics. They also discussed the agency’s response to the current shortages in oncology drugs.

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