FDA advisory panel backs Grail's Galleri multi-cancer blood test, citing benefits outweigh risks

The Food and Drug Administration’s advisory committee voted to endorse Galleri, a blood test from Grail that screens for multiple cancers, saying the benefits outweigh the risks.

The panel’s vote was unanimous on safety (10-0), split 6-4 on effectiveness, and 7-2 with one abstention on the overall benefit-risk for patients who meet the specified criteria.

Although the FDA is not required to follow the advisory panel’s recommendation, it historically gives weight to such endorsements, suggesting a favorable outlook for eventual regulatory clearance of Galleri.