The Galleri MCD vote: What FDA asked its advisors to ignore

In this episode of The Cancer Letter Podcast, Paul Goldberg, editor and publisher of The Cancer Letter, Jacquelyn Cobb, managing editor, discuss the Sept. 23 meeting of the FDA Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee, during which the panel voted in favor of Galleri, the multi-cancer detection test from GRAIL Inc., to become the first multi-cancer detection test to receive regulatory approval.At the advisory committee meeting, FDA put to rest the question of how it will assess multi-cancer screening tests. Reduction in mortality as shown through a randomized controlled trial, the standard measure of clinical benefit for a screening test will not be considered for approval of Galleri, FDA said. Surrogate metrics for clinical benefit, such as stage shift, would not be considered as part of the PMA, either, the agency said.“The problem with this thing is how many science writers actually understand the subtle concepts we're kicking around here right now? The answer is not many. How many doctors understand it? The answer is not many. What will happen to patients? And that's where I kind of lose sleep. So, people get that test because they're nervous, because they're cancer-phobic, which is a reasonable thing. I have it. Cancer-phobia, I have a bad case.”The agency repeatedly told the panel members to limit the scope of discussion to the ability of Galleri to detect cancers in asymptomatic individuals. The advisors were instructed not to get stumped on questions of whether the test can provide any clinical benefit, such as a decrease in mortality.In this episode of The Cancer Letter Podcast, you can hear this exchange first-hand.This episode is sponsored by Fox Chase Cancer Center. Learn more at https://www.foxchase.org/discovery.Stories mentioned in this podcast include:The Directors: Two Gulf Coast cancer center directors on why NCI designation matters—and why they want it Lucio Miele and Raghu KalluriFDA advisory committee votes in favor of Galleri approval, but calls for removal of “early” detection claimsTrump weighs—and abandons—an executive order that would give OMB veto power over NIH grants When did stage 3B lung cancer become “early stage”?How biology is reshaping breast cancer careAt confirmation hearing, Heidi Overton sidesteps questions about FDA regulation of fruit-flavored vapes