FDA Approves FoundationOne Liquid CDx as a Companion Diagnostic for Entrectinib

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

  1. 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
  2. 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
  3. 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
  4. 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