临床与研发

I’m following the FDA advisory committee on $GRAL’s Galleri blood test for detecting multiple types of cancer today and will be posting my thoughts here. So far, we’ve seen only company presentations, usually the dullest part of an advisory panel. But there have been some interesting tidbits. First, Grail is leaning heavily into simply the idea that they detect more cancers and can localize them, not getting into larger questions about the benefit to patients from doing so. See this slide. Speaking as part of Grail’s presentation, Mylynda Massart, a family medicine at UPMC, argued that the test can fit will with existing cancer screening and is something that many patients are eager to use. The panelists, in their first questions, expressed skepticism. One asked if the incredible, white-glove treatment that Grail gives doctors now can really scale. Another responded a Grail comment: “You’re carefully choosing your words. It is curative intent but you do not have outcome data.” Another panelist asked why the control arm of Grail’s randomized clinical trial in the UK was not included in the briefing document; the primary outcome of that trial was not included, either. Grail and FDA said that based on the agreement they came to with the FDA. Another panelist asked why so many patients from Grail’s other big study were not included in the briefing material; Grail said that had to do with when the data were submitted. What’s interesting is that the FDA seems to be telling the panel to limit the scope of its discussion. An FDA official said that both follow-ups and outcome data were beyond the scope of the claim being considered.