May 15, 2025
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February 20, 2026
Friends of Cancer Research at a meeting earlier this month presented new data from its ctMoniTR project that it believes may help validate the use of circulating-tumor DNA as an early endpoint in clinical trials for oncology therapies. The project began more than five years ago with an initial proof-of-concept analysis combining various independent data sets to…
Read MoreFebruary 19, 2026
Researchers evaluated different artificial intelligence models for assessing HER2 expression and found they had the lowest agreement when identifying HER2-low samples, a similar challenge faced by pathologists scoring HER2 expression based on immunohistochemistry (IHC) staining. In a study, published in Modern Pathology earlier this month, researchers tested the agreement on HER2 expression results between 10 different computational pathology…
Read MoreFebruary 18, 2026
Optimization and validation are needed to achieve ctDNA’s highest-priority application: surrogate endpoint for early cancer trials There’s a compelling case for validating reduction in circulating tumor DNA (ctDNA) as a surrogate endpoint in solid tumor studies. Done right, ctDNA could shrink trials and accelerate development by providing an earlier — and potentially more sensitive —…
Read MoreFebruary 12, 2026
Late last year, the FDA proposed a sweeping change to the regulation of certain cancer-linked tests, regulating them as Class II devices. The proposal was open for comment through January 2026, and industry has weighed in with a list of priorities for the agency, including choosing the right pathway and airing long-standing concerns about validation…
Read MoreFebruary 11, 2026
A newly published staff manual for the FDA Commissioner’s National Priority Voucher program provides the most extensive documentation yet for an initiative that has come under criticism for its lack of transparency. The FDA plans to provide additional information, including possibly draft guidance, in the “coming months,” according to newly updated information on the agency’s…
Read MoreFebruary 10, 2026
The public qualification pathway created in the 21st Century Cures Act has “not lived up to its billing,” but draft commitment letter language could help to address funding, expertise and incentive shortfalls. Key Takeaways The FDA biomarker qualification program established in the 21st Century Cures law is under-utilized and under-resourced. The FDA and industry agreed…
Read MoreFebruary 9, 2026
A meeting hosted by Friends of Cancer Research put a spotlight on the rising potential of circulating tumor DNA and AI-enabled tumor assessment in cancer drug development. An FDA program designed to validate biomarkers for regulatory use may be ill-suited to quickly advance these tools and others like them, however. Background on biomarker development Biomarkers…
Read MoreFebruary 5, 2026
An FDA program that seeks to expedite drug reviews for companies in line with the Trump administration’s priorities should focus on efficiency in evaluations, not speed, the agency’s former drughead said Thursday. “This voucher program has an emphasis on speed, which I think is a very sophomoric aim at aspiration,” said Richard Pazdur, who briefly…
Read MoreJanuary 6, 2026
The nonprofit Friends of Cancer Research (Friends) held its annual meeting exploring innovative ways to streamline clinical trials safely to bring effective therapies to patients earlier. Friends has strongly supported faster approval of effective cancer drugs, including the Breakthrough Therapy designation at the U.S. FDA. The annual meeting was held during the government shutdown. Friends…
Read MoreDecember 19, 2025
The agency’s high-level turnover and conflicting policy decisions on drug oversight have fueled concerns about the leadership of Dr. Marty Makary. Days after a division chief at the Food and Drug Administration resigned amid accusations that he used his federal power to seek revenge on a former business associate, the scandal took on a new…
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