Drugs

Using AI in Tumor Assessment

A new Friends of Cancer Research white paper, “Leveraging AI-Enabled Tumor Assessment Tools on Radiological Images to Evaluate Treatment Effect and Support Clinical Trial Endpoints in Solid Tumors,” presents findings from a multi-stakeholder working group it convened to evaluate the current landscape of artificial intelligence (AI)-enabled tumor assessment tools and propose a stepwise roadmap for integration into clinical trials. The white paper outlines:

limitations of current imaging-based endpoints and opportunities to improve upon the Response Evaluation Criteria in Solid Tumors (RECIST);
emerging AI-driven approaches, including enhanced RECIST, radiomics, volumetric analysis, and growth kinetics; and
necessary components of a framework to validate a novel AI-imaging-based endpoint as an early endpoint, including outstanding questions for defining the endpoint and considerations for a meta-analysis.

“By advancing and aligning on methodological standards,” the paper says, “the oncology community can enable AI-enabled tumor assessments to supplement, and in some cases surpass, traditional measurement approaches in clinical trials. This shift has the potential to improve endpoint precision, reduce trial timelines and costs, and ultimately accelerate patient access to safe and effective therapies.”

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