As the oncology community waits with bated breath for a possible FDA approval of GRAIL’s Galleri test, NCI Director Anthony Letai has a lot to say about multi-cancer detection tests—particularly Galleri.
Letai spoke at a National Comprehensive Cancer Network policy summit on screening and prevention last week on Oct. 6.
“It’s very important when we consider screening studies that we don’t, in our minds, project the ideal screening test that we have in mind, but actually the real test that we have on hand,” Letai said at the summit. “Even though we aspire to ideal tests, projecting sub-ideal tests across a large population can cause harm—both financial and real, physical harm.”
In this episode of The Cancer Letter Podcast, Paul Goldberg, editor and publisher of The Cancer Letter, and Sara Willa Ernst, reporter, discuss Letai’s remarks. FDA approval for Galleri seems likely after an advisory committee voted in favor of the test during a Sept. 23 meeting.
“Now we’re waiting. What will FDA do when they have this recommendation from the advisory committee?” Sara said.
The FDA panel voted that the test was safe, effective, and that the benefits outweigh the risks. This recommendation did not consider questions of clinical benefit.
“FDA seems to be perfectly happy with sidestepping the question of benefit,” Paul said. “If FDA is not going to care about patient benefit in this case, who does?”
Letai’s comments about MCDs were “very consistent with what Phil Castle, the director of the [NCI] Division of Cancer Prevention, was saying—basically, who is going to ask questions of patient benefit?” Paul said.
If Galleri is approved by FDA, the test may sail down a shorter path to widespread Medicare coverage and bypass the usual need for a recommendation by the U.S. Preventative Services Task Force, which usually takes years.
“I have some concerns about this,” Letai said about the panel’s vote. “My concerns are that people overestimate the performance of this assay.”
This episode is sponsored by City of Hope. Learn more at www.cityofhope.org.
Stories mentioned in this podcast include:
A transcript of this podcast is available: https://cancerletter.com/podcastc/20261014-galleri/
