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www.fdanews.com/articles/208475-fda-approves-foundation-medicines-companion-diagnostic-for-genentechs-rozlytrek

FDA Approves Foundation Medicine’s Companion Diagnostic for Genentech’s Rozlytrek

July 6, 2022

Cambridge, Mass.-based Foundation Medicine has received premarket approval from the FDA for its FoundationOne CDx, a companion diagnostic for Genentech’s cancer dug Rozlytrek (entrectinib).

FoundationOne CDx can be used to identify patients with ROS1-positive nonsmall-cell lung cancer (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 FDA approval, Foundation Medicine will conduct a post-approval study using the Flatiron Health-Foundation Medicine Clinico-Genomic Database, which contains more than 100,000 linked genomic profiles.

NSCLC is the most common type of lung cancer, accounting for up to 85 percent of all lung cancer diagnoses, the company said.

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