FDA Advisers Back Grail's Galleri Blood Test in Key Cancer Screening Vote
A US FDA advisory panel voted 7-2, with one abstention, that Grail's Galleri blood test's benefits outweigh its risks, moving the multi-cancer screening tool closer to approval.
An independent panel of experts advising the US Food and Drug Administration has concluded that the benefits of Grail's blood-based cancer detection test outweigh its risks, a decision that could open the door to a landmark approval in cancer screening.
The committee voted 7-2, with one abstention, in favour of the test, known as Galleri, citing its ability to detect cancers that are otherwise difficult to find in adults aged 50 and older. The panel was unanimous in endorsing the test's safety, though members were divided 6-4 on whether the available evidence demonstrated its effectiveness.
The FDA is not obligated to follow its advisory panels' recommendations, but it generally gives them considerable weight. A final ruling on whether Galleri can be marketed across the United States is anticipated in the coming months.
"This increases our confidence even more on FDA approval — almost derisked," said Subbu Nambi, an analyst at Guggenheim. He noted that questions remain about the label, but added, "we ultimately think FDA will approve for a wide range of cancers."
Galleri screens for multiple cancers from a single blood draw. In a US study, it identified 35% of cancers within 12 months and recorded a specificity of 99.85%. Findings from a separate British study were broadly consistent, reinforcing the test's low false-positive rate and its cancer-detection capabilities.
Dr. Marc Matrana, a medical oncologist at Ochsner MD Anderson Cancer Center and a principal investigator on one of Grail's trials, described the development as a major shift. Speaking before the meeting, he pointed to strong patient interest in the test.
The committee also stressed that physicians must clearly communicate the test's limitations to patients, so that they do not forgo established screenings such as mammograms and colonoscopies. Members urged that Galleri be used as an "addition, not substitution" to standard care.
Both Grail's Galleri and Abbott's Cancerguard are currently available to patients under Clinical Laboratory Improvement Amendments regulations, but neither has received FDA approval.