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FDA Panel Endorses Grail's Multicancer Test, Cautions on Data Gaps
Developing
In Short: An FDA advisory panel has voted that Grail's Galleri multicancer detection test is safe and effective, with benefits outweighing risks, but highlighted significant data gaps.
An FDA advisory panel voted that Grail's Galleri multicancer detection test is safe and effective, with benefits outweighing risks, but emphasized the lack of evidence showing that the test reduces mortality.
The panel's votes on safety, effectiveness, and the balance of risks and benefits do not constitute an explicit approval of the test.
Committee member Stanley Lipkowitz, MD, PhD, deputy director at the National Cancer Institute, noted, 'As an oncologist, I generally look at that as outcomes, and we don’t have that data.
Panelists also called for more postmarketing data to determine whether the test has any impact on mortality and to establish an appropriate testing interval.
What this adds
The advisory panel's decision does not guarantee approval of the Galleri test, as the committee did not explicitly vote on whether to approve the MCED test.
Some panel members expressed concern that approval could lead to widespread testing outside the intended use, potentially without clear population-wide benefits.
Background
An FDA advisory panel voted that Grail's Galleri multicancer detection test is safe and effective, with benefits outweighing risks, but highlighted significant data gaps.
What's still developing
- Some panel members expressed concern that approval could unleash a rush of testing outside of the indicated use, and that although MCED testing might help individual patients, it may not have population-wide benefit.