FDA Approves FoundationOne Liquid CDx as a Companion Diagnostic for Entrectinib

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The FDA has approved FoundationOne Liquid CDx as a companion diagnostic for use with the selective TKI entrectinib. The assay identifies patients with ROS1-positive NSCLC or NTRK fusion–positive solid tumors who do not have a tissue sample available and who may be appropriate for entrectinib treatment.

The FDA has approved FoundationOne Liquid CDx as a companion diagnostic for use with the selective TKI entrectinib (Rozlytrek). The assay identifies patients with ROS1-positive non–small cell lung cancer (NSCLC) or NTRK fusion–positive solid tumors who do not have a tissue sample available and who may be appropriate for entrectinib treatment.¹

ROS1 gene fusions are present in 1% to 2% of NSCLC diagnoses, while NTRK gene fusions appear in approximately 0.3% of all solid tumors, including breast, cholangiocarcinoma, colorectal, gynecological, neuroendocrine, NSCLC, salivary gland, pancreatic, sarcoma, and thyroid cancers.^2,3

FoundationOne Liquid CDx analyzes circulating cell-free DNA isolated from plasma derived from anticoagulated peripheral whole blood of patients with advanced cancer to detect genomic alterations 324 cancer-related genes. The assay is now approved as a companion diagnostic for 9 targeted therapies.

“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, PhD, chief medical officer at Foundation Medicine, said in a news release. “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.”

The regulatory agency approved FoundationOneCDx, Foundation Medicine’s tissue-based comprehensive genomic profiling (CGP) test, for use with entrectinib in this same patient population in June 2022.⁴

Last year’s approval was based on findings from several studies, including the phase 1 ALKA-372-001 (EudraCT 2012-000148-88), phase 1 STARTRK-1 (NCT02097810), and phase 2 STARKTRK-2 (NCT02568267) trials. As part of the approval, the FDA has added a condition where a post-approval study must be conducted by the Flatiron Health-Foundation Medicine’s Clinico-Genomic Database to continue to identify patients with ROS1 fusion–positive NSCLC who would benefit from entrectinib.

References

FoundationOne Liquid CDx Receives FDA Approval as a Companion Diagnostic for Rozlytrek® (entrectinib). News release. Foundation Medicine. January 4, 2023. Accessed January 5, 2023. https://bwnews.pr/3jMFmG5
U.S. FDA approves Foundation Medicine’s FoundationOneCDx as a companion diagnostic for Roche’s Rozlytrek® (entrectinib). News release. Foundation Medicine. June 9, 2022. Accessed January 5, 2023. https://bit.ly/3Gkpn9P
Westphalen, C.B., Krebs, M.G., Le Tourneau, C. et al. Genomic context of NTRK1/2/3 fusion-positive tumours from a large real-world population. NPJ Precis Onc. 2021;5(1):69. doi:10.1038/s41698-021-00206-y
Demetri GD et al. Efficacy and Safety of Entrectinib in Patients with NTRK Fusion-Positive (NTRK-fp) Tumors: Pooled Analysis of STARTRK-2, STARTRK-1 and ALKA-372-001. Presented at ESMO 2018; October 19-23, 2018; Munich, Germany. Abstract LBA17