Foundation Medicine gets FDA nod for NSCLC CDx

2019 10 09 17 32 0093 Dna Cancer Cell 400

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.

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