Foundation Medicine has received conditional approval from the U.S. Food and Drug Administration (FDA) for the use of its FoundationOne CDx test as a companion diagnostic test for the two indications of Rozlytrek (entrectinib).
Rozlytrek is a targeted therapy for the treatment of non-small cell lung cancer (NSCLC) developed by Roche's Genentech.
As a companion diagnostic, FoundationOne CDx can be used to identify patients with ROS1-positive NSCLC or patients with neurotrophic tyrosine receptor kinase (NTRK) fusion-positive solid tumors who may be appropriate for treatment with Rozlytrek.
As a condition of the approval, Foundation Medicine will conduct a post-approval study to further demonstrate FoundationOne CDx's ability to identify NSCLC patients with ROS1 fusions who may respond to Rozlytrek.
