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Alexander Drilon, MD

Gregory J. Riely, MD, PhD


FDA Approves Companion Diagnostic for Entrectinib in Treatment of NTRK Fusion–Positive Tumors

By: JNCCN 360 Staff
Posted: Friday, January 6, 2023

On January 4, Foundation Medicine, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved FoundationOne®Liquid CDx to be used as a companion diagnostic to identify patients with NTRK fusion–positive solid tumors or ROS1-positive non–small cell lung cancer (NSCLC) who do not have a tissue sample available and may be appropriate for treatment with the targeted therapy entrectinib (Rozlytrek). This companion diagnostic is the first and only blood-based companion diagnostic approved for entrectinib. This decision from the FDA follows the approval in 2022 of Foundation Medicine’s tissue-based comprehensive genomic profiling test, FoundationOne®CDx, for the same therapy.

This qualitative, next generation sequencing–based, in vitro diagnostic test uses targeted high throughput hybridization–based capture technology to analyze 324 genes for genomic alterations via circulating cell-free DNA isolated from plasma derived from anticoagulated peripheral whole blood of patients with advanced cancer. The genomic profiling test is used to identify rare mutations, including NTRK and ROS1. Although NTRK gene fusions occur in roughly 0.3% of all solid tumors, they can be found in many tumor types, including breast, cholangiocarcinoma, colorectal, gynecologic, neuroendocrine, NSCLC, salivary gland, pancreatic, sarcoma, and thyroid cancers. ROS1 gene fusions are seen in about 1% to 2% of NSCLC diagnoses.

For the complete label, including companion diagnostic indications and complete risk information, visit

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