FDA to release list of surrogate endpoints in oncology

Scott Gottlieb, FDA Commissioner, said Monday at the National Press Club in Washington, DC that his agency will release a list of surrogate endpoints used in cancer drug development soon.

Scott Gottlieb

His speech touched on four topics — including modernizing the trial process and enabling payers to leverage more open access to real world data. “In the coming weeks, for the first time, CDER will publish on the web, a list of the surrogate endpoints that were the primary basis of approval or licensure of a drug or biological for both accelerated and traditional approvals,” he said.

He noted the industry needs to modernize drug development to meet the rapid pace of science while ensuring products remain available at a reasonable cost.

“A recent letter in the New England Journal of Medicine noted that the overall response rate — both complete and partial tumor responses — in Phase 1 oncology trials was 20 percent,” he said according to the transcript.

“This mirrors the FDA’s internal analysis, where we’ve found that Phase 1 trials that are based on an enrichment design – in other words, trials where the patients are selected for a treatment based on how their tumors express a specific biomarker — are associated with a significantly higher probability of demonstrating a clinical benefit than those that are not,” he added.

Recently released data from the National Cancer Institute’s Surveillance, Epidemiology and End Results program shows that between 2011 and 2015, overall cancer death rates decreased 1.8% annually for men, and 1.4% for women.

Eleven of the 18 most common cancers in men showed decreases in mortality, Gottlieb said. And fourteen of the 20 most common cancers in women showed decreases in mortality.

These included leukemia, melanoma, myeloma, non-Hodgkin lymphoma, and cancers of the colon and rectum, breast, cervix, ovaries, esophagus, kidney, larynx, lung and bronchus, prostate and stomach.

“Lung and bronchial cancer — among the most feared and rapidly fatal cancers — had the greatest decrease in mortality in men; and non-Hodgkin lymphoma had the greatest decrease in women. Early detection was one key for many of these diseases. But so were advances in care,” he added.

First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email for more information. 

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VP Oncology Biology
Skyhawk Therapeutics Waltham, MA
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Elektroki Boston, MA
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Elektroki Boston, MA
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Recursion Pharmaceuticals Salt Lake City, UT

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