The Food and Drug Administration has approved the Praxis Extended RAS Panel for the identification of metastatic colorectal cancer patients who can be treated with panitumumab.
The Praxis Extended RAS Panel is able to detect 56 specific mutations in the RAS genes of mCRC patients, and is the first next generation sequencing test approved by the FDA capable of testing more than one RAS gene mutation. If RAS mutations are not detected, then panitumumab is indicated, and if a mutation is detected, panitumumab is not indicated, according to the FDA statement .
Approval was based on a retrospective analysis of available samples from mCRC patients who were enrolled in a clinical trial evaluating panitumumab plus FOLFOX versus FOLFOX alone.
“Panitumumab’s product labeling has been modified to align the indication for panitumumab and intended use for the Praxis Extended RAS Panel,” the FDA noted.