FDA Approves FoundationOne Companion Diagnostic to Entrectinib in NSCLC


The FDA has approved the liquid biopsy next-generation sequencing-based test FoundationOne Liquid CDx in companion with entrectinib for patients with non–small cell lung cancer with a ROS1 mutation in their tumor.

The FDA has approved the use of FoundationOne Liquid CDx as a companion diagnostic tool to help identify if patients with non–small cell lung cancer (NSCLC) are positive for the ROS1 mutation and may be eligible for treatment with entrectinib (Rozlytrek).1

This comprehensive genomic profiling test allows for a wider subset of patients to be tested and potentially treated with a targeted therapy by utilizing a patient’s blood sample and analyzing 300 cancer-related genes for genomic alterations. ROS1 gene fusions are also seen in 1%-2% of NSCLC diagnoses and NSCLC accounts for 80%-85% of all lung cancer diagnoses.2,3

“With the most FDA-approved companion diagnostic claims of any blood-based comprehensive genomic profiling test, FoundationOne Liquid CDx is an accessible tool for evidence-based, guideline-adherent therapy selection,” Mia Levy, MD, chief medical officer at Foundation Medicine, said in a press release.

The next-generation sequencing (NGS)-based in vitro diagnostic test is also approved for patients with NTRK fusion-positive solid tumors that do not have a tissue sample available and may also be eligible for treatment with the selective tyrosine kinase inhibitor (TKI). According to Foundation Medicine, the manufacturer of the test, this is the first and, so far, only blood-based companion diagnostic approved for use with entrectinib.

FoundationOne CDx detects substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements. It can also detect genomic signatures that include microsatellite instability and tumor mutational burden in a patient’s tumor by using DNA isolated from formalin-fixed, paraffin-embedded tumor tissue specimens.

The FDA previously approved the non-liquid biopsy version of FoundationOne CDx in conjunction with entrectinib based on data from the phase 1 ALKA-372-001 (EudraCT 2012-000148-88), phase 1 STARTRK-1 (NCT02097810) and phase 2 STARKTRK-2 (NCT02568267) trials.4 These studies showed the usefulness of entrectinib in patients with tumors that had ROS1 mutations that were identified with the use of the NGS test.

“Liquid biopsies can make molecular testing possible for patients when tissue is not available and we’re excited that just over 6 months after the approval of our tissue-based test as a companion diagnostic for [entrectinib], our blood-based test can now also be offered to support doctors in connecting their patients with this targeted treatment option,” said Levy.


FoundationOne®Liquid CDx receives FDA approval as a companion diagnostic for Rozlytrek® (entrectinib). News Release. January 4, 2023. Accessed January 5, 2023. https://yhoo.it/3VMQPCX
Westphalen CB, Krebs MG, Le Tourneau C, et al. Genomic context of NTRK1/2/3 fusion-positive tumours from a large real-world population. NPJ Precis Oncol. 2021 Jul 20;5(1):69. doi:10.1038/s41698-021-00206-y
Targeted drug therapy for non-small cell lung cancer. American Cancer Society. December 13, 2022. Accessed January 5, 2023. https://bit.ly/3QkLIZz
U.S. FDA approves Foundation Medicine’s FoundationOne®CDx as a companion diagnostic for Roche’s Rozlytrek® (entrectinib). News Release. Roche. June 9, 2022. Accessed January 5, 2023. https://bit.ly/3GkdCAj
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