FDA 顾问委员会就 Grail 旗下 Galleri 多癌种血液筛查试验的三项投票问题给出结果:安全性问题 10 票赞成、0 票反对、0 票弃权;有效性问题 6 票赞成、4 票反对、0 票弃权;获益大于风险问题 7 票赞成、2 票反对、1 票弃权。
FDA 专家委员会对 Galleri 多癌种筛查试验的三项投票结果,呈现了有效性与获益风险上的分歧。
Here is how the panel voted on each voting question on $GRAL's Galleri screening test for many types of cancer. Yes, No, or abstain.
1. Is there reasonable assurance that Galleri is safe for use in patients who meet the criteria specified in the proposed indication?
Y: 10
N: 0
A: 0
2. Is there reasonable assurance that Galleri is effective for use in patients who meet the criteria specified in the proposed indication?
Y: 6
N: 4
A: 0
3. Do the benefits of Galleri outweigh the risk for use in patients who meet the criteria specified in the proposed indication?
Y: 7
N: 2
A: 1
I'm live-tweeting the afternoon discussion of the FDA's advisory committee meeting on $GRAL's blood test to detect multiple types of cancer. This is a very interesting screening test. It definitely identifies cancers. But there are a good number of people who do not have cancer who will get a positive result, and a lot of patients who will get a negative result who do have cancer. One really big question is whether it's really right to say this test identifies cancer "early." And even tougher one is how to think about a test that might make patients skip existing screening tests -- that could mean, for instance, that more breast or colorectal cancers might be missed. The public hearing was very interesting. Some speakers, like Phil Castle from NCI, worried about the false negatives. There were also patients who felt they had been saved by the results of the test. I'll be threading my notes from the afternoon here. Forgive me for typos -- these things move fast.在 X 查看被引用的帖子
来源:Matthew Herper · x.com