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FDA Brief: Companion Diagnostic for Entrectinib Receives Approval

By: Lauren Velentzas
Posted: Friday, June 10, 2022

Yesterday, Foundation Medicine, Inc., announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne CDx, a companion diagnostic for the TRK inhibitor entrectinib to identify patients with ROS1-positive non–small cell lung cancer (NSCLC) or patients with NTRK fusion–positive solid tumors who may be appropriate for treatment with entrectinib. FoundationOne CDx is the first and only FDA-approved companion diagnostic to identify patients for whom treatment with entrectinib may be appropriate.

The approval is based on data from three trials: the phase I ALKA-372-001 trial, the phase I STARTRK-1 trial, and the phase II STARKTRK-2 trial. As a condition of this approval, Foundation Medicine must conduct a postapproval study using the Flatiron Health–Foundation Medicine’s Clinico-Genomic Database, a de-identified, Health Insurance Portability and Accountability Act (HIPAA)-compliant database that links outcomes data from Flatiron’s network of oncology clinics and genomic data from Foundation Medicine’s comprehensive genomic profiling assays.

FoundationOne CDx analyzes more than 300 cancer-related genes for genomic alterations using a tissue sample from a patient’s tumor. The test is approved as a companion diagnostic for 25 indications and 3 group claims across 30 targeted therapies.


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