Diagnostics
FDA advisers back Grail’s Galleri blood test for multiple cancers
The panel said Galleri’s benefits outweigh its risks for adults 50 or older, but it should not replace standard cancer screenings.
An FDA advisory panel backed Grail’s Galleri blood test, voting that its benefits outweigh its risks for adults aged 50 years or older, the group for which Grail is seeking U.S. approval. Members voted 7 to 2, with one abstention, on the benefit-risk question. They voted 6 to 4 that the test is effective and unanimously that it is safe, according to Healio.
Panel members cautioned that the evidence does not yet show whether detecting cancer signals leads to better clinical outcomes. They also said Galleri should be used alongside, not instead of, guideline-recommended screenings. The test looks for cancer signals in blood and is intended to identify multiple cancers.
The NHS-Galleri trial did not meet its primary endpoint of reducing diagnoses at stage III or stage IV across 12 cancer types, reports said. The FDA is not required to follow its advisers’ recommendation. Grail expects a final FDA decision in the coming months, Medical Xpress reported.
Reporting on this story
- BioPharma Dive Grail multicancer detection test wins FDA advisers’ backing (opens in a new tab)
- Healio FDA panel supports multicancer early detection test (opens in a new tab)
- MedPage Today FDA Advisors Recommend Galleri Multicancer Blood Test (opens in a new tab)
- Fierce Biotech Grail survives adcomm vote as it awaits FDA decision for cancer blood test (opens in a new tab)
- The Hill FDA panel endorses first-of-a-kind cancer blood test from Grail (opens in a new tab)
- Medical Xpress FDA panel narrowly backs multi-cancer blood test despite doubts it works (opens in a new tab)
