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FDA Approves Foundation Medicine Assay as CDx for Certain NSCLC Therapies

NEW YORK – Foundation Medicine said Wednesday its FoundationOne Liquid CDx test has been approved by the US Food and Drug Administration as a companion diagnostic for epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI).

The Cambridge, Massachusetts-based Roche subsidiary said the test is approved to identify non-small cell lung cancer patients whose tumors have EGFR exon 19 deletions or exon 21 L858R substitutions and are likely to benefit from treatment with FDA-approved EGFR TKIs. The test can be used with Genentech's Tarceva (erlotinib), AstraZeneca's Tagrisso (osimertinib), and AstraZeneca's Iressa (gefitinib), and it will be eligible for use as a companion diagnostic for other TKIs that gain FDA approval.

“Following three recent group companion diagnostic approvals for Foundation Medicine’s tissue-based test, FoundationOne CDx, this first group approval for FoundationOne Liquid CDx builds upon the momentum for more efficient and innovative regulatory approaches to the companion diagnostic approval process," Mia Levy, Foundation Medicine's chief medical officer, said in a statement. "These efforts help to maintain the high-quality standards and rigor of the process while streamlining the approach to developing TKIs to get these treatments to patients faster."

Foundation Medicine said in June it had secured FDA approval for use of the FoundationOne CDx test as a companion diagnostic to identify patients with ROS1 fusion-positive non-small cell lung cancer or patients with NTRK fusion-positive solid tumors who could benefit from Roche's Rozlytrek (entrectinib). In September, the firm said it was also collaborating with Day One Biopharmaceuticals to develop FoundationOne CDx as a companion diagnostic for Day One's investigational drug tovorafenib, which is being evaluated for treatment of relapsed pediatric low-grade glioma, and with Relay Therapeutics to develop the test as a companion diagnostic for Relay's RLY-4008 investigational FGFR2 inhibitor for use in patients with FGFR2-mutated bile duct cancer and other solid tumors.

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