FDA Approves FoundationOne Liquid CDx to Identify Genomic Profile in NSCLC

The FDA has approved FoundationOne Liquid CDx (Foundation Medicine) to be used as a companion diagnostic to identify individuals with ROS1-positive non–small cell lung cancer (NSCLC) or those with NTRK fusion-positive solid tumors, who do not have a tissue sample available and may be eligible for treatment with entrectinib (Rozlytrek; Genentech).¹

FoundationOne Liquid CDx is the only blood-based companion diagnostic approved for entrectinib. This decision follows the approval of Foundation Medicine’s tissue-based comprehensive genomic profiling (CGP) test for the same therapy last year.¹

“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 statement.¹ “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.”.¹

CGP is an important tool to determine harder-to-find mutations, such as ROS1, seen in approximately 1% to 2% for SCLC diagnoses, and NTRK, seen in approximately 0.3% of all solid tumors, according to the statement.

The tumor types can include breast, cholangiocarcinoma, colorectal, gynecological, NCSLC, neuroendocrine, pancreatic, salivary gland, sarcoma, and thyroid.¹

Using a blood sample, FoundationOne Liquid CDx can analyze more than 300 genes that genomic alterations that results in cancer growth. It is now approved as a companion diagnostic for 9 targeted therapies.¹

Both FDA-approved tests meet rigorous analytical and clinical validation standards.

In 2022, the FDA approved FoundationOne CDx for the same indication. The FoundationOne CDx is a CGP pan-tumor tissue biopsy test that assesses an individual’s cancer and identifies the unique molecular “fingerprint” of the tumor.²

make informed and personalized treatment decisions, hopefully achieving better clinical outcomes.²

Reference

1. FoundationOne Liquid CDx receives FDA approval as a companion diagnostic for Rozlytrek (entrectinib). Business Wire. News release. January 4, 2022. Accessed January 6, 2023. https://www.businesswire.com/news/home/20230104005548/en

2. Gallagher, A. FDA approves FoundationOne CDx for use with entrectinib For NSCLC, solid tumors. June 23, 2022. Accessed January 6, 2023. https://www.pharmacytimes.com/view/fda-approves-foundationone-cdx-for-use-with-entrectinib-for-nsclc-solid-tumors