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FDA Approves Foundation Medicine Test as CDx With Roche's Rozlytrek

NEW YORK – Roche subsidiary Foundation Medicine announced on Thursday that its FoundationOne CDx test has been approved by the US Food and Drug Administration as a companion diagnostic with Roche's Rozlytrek (entrectinib). 

The test was approved by the FDA to identify patients with ROS1 fusion-positive non-small cell lung cancer or patients with NTRK fusion-positive solid tumors for whom treatment with Rozlytrek could be appropriate. It is the first and only FDA-approved CDx for this indication, Roche said in a statement. As a condition of the test's approval, Foundation will conduct a study to further demonstrate FoundationOne CDx's ability to identify patients with ROS1 fusion-mutated NSCLC who could potentially benefit from Rozlytrek.

Rozlytrek is a targeted therapy approved to treat ROS1 fusion-positive metastatic NSCLC and a tumor-agnostic medicine for locally advanced or solid tumors that have NTRK fusions. In 2019, the FDA granted accelerated approval to the drug as a treatment for adult and adolescent patients whose cancers have NTRK gene fusions and are out of treatment options, as well as for adults with metastatic non-small cell lung cancer whose tumors are ROS1-positive.

"The ability to tailor cancer therapies based on specific genomic alterations using validated comprehensive genomic profiling (CGP) has transformed the traditional 'one-size fits-all' approach to cancer," Levi Garraway, Roche's chief medical officer and head of global product development, said in a statement. "This approval marks a significant step forward in expanding treatment options and improving outcomes for patients, particularly those with rare tumors."