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U.S. FDA Approves FoundationOne®CDx as a Companion Diagnostic for Rozlytrek® (entrectinib)

FoundationOne®CDx is now approved to identify patients with ROS1-positive non-small cell lung cancer or patients with NTRK fusion-positive solid tumors who may be appropriate for treatment with Rozlytrek (entrectinib)

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for the two indications of Rozlytrek® (entrectinib), a targeted therapy developed by Genentech, a member of the Roche Group. As a companion diagnostic, FoundationOne CDx can be used to identify patients with ROS1-positive non-small cell lung cancer (NSCLC), or patients with Neurotrophic Tyrosine Receptor Kinase (NTRK) fusion-positive solid tumors who may be appropriate for treatment with Rozlytrek (entrectinib).

“Comprehensive and validated genomic testing is critical to identify patients with ROS1 or NTRK gene fusions as they are rare and can be missed when more limited or unvalidated testing panels are used to profile a patient’s tumor,” said Mia Levy, M.D., Ph.D., chief medical officer at Foundation Medicine. “We’re proud that this companion diagnostic will enable broader access to genomic testing and this breakthrough therapy, ultimately allowing more patients to benefit from precision medicine.”

As a condition of this approval, Foundation Medicine will conduct a post-approval study powered by the Flatiron Health-Foundation Medicine Clinico-Genomic Database (CGDB) to further demonstrate FoundationOne CDx’s ability to identify NSCLC patients with ROS1 fusions who may respond to Rozlytrek (entrectinib). The CGDB is a de-identified, HIPAA-compliant database that links outcomes data from Flatiron’s network of oncology clinics and genomic data from Foundation Medicine’s CGP assays. The database currently contains more than 100,000 linked genomic profiles.

“We look forward to our ongoing partnership with Genentech and Flatiron Health as we implement this novel approach to post-approval evidence generation through our CGDB,” said Sanket Agrawal, chief biopharma business officer at Foundation Medicine. “This database is an invaluable asset for cancer research, especially in rare patient populations, like ROS1-mutated NSCLC. We are well-positioned to support our biopharma partners with this unique resource as we continue accelerating access to new precision medicines.”

NSCLC is the most common type of lung cancer, accounting for 80 to 85 percent of all lung cancer diagnoses.1 When ROS1 gene fusions occur, generally in 1-2 percent of NSCLC diagnoses, 2 cancer cells grow and proliferate in an uncontrolled manner. NTRK gene fusions occur when NTRK1/2/3 genes fuse with other genes, resulting in altered TRK proteins, which can activate signaling pathways involved in proliferation of certain types of cancer. Though rare, occurring in roughly .3 percent of all solid tumors,3 these fusions can be found in many tumor types, including breast, cholangiocarcinoma, colorectal, gynecological, neuroendocrine, non-small cell lung, salivary gland, pancreatic, sarcoma and thyroid cancers.4 CGP is an important tool for identifying these rare mutations.

Using a tissue sample, FoundationOne CDx analyzes more than 300 cancer-related genes for genomic alterations in a patient’s tumor. The test is FDA-approved as a companion diagnostic for 25 CDx indications, and 3 group claims across 30 targeted therapies, demonstrating Foundation Medicine’s deep regulatory expertise. FoundationOne CDx is also the first and only companion diagnostic approved for Rozlytrek (entrectinib).

About FoundationOne CDx
FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit

About Foundation Medicine: Your Essential Partner in Cancer Care
Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research. We collaborate with a broad range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership. Our deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and empowers researchers to develop new medicines. Every day, we are driven to help our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, please visit us on and follow us on Twitter and LinkedIn.

Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc.

Source: Foundation Medicine

1 American Cancer Society. What Is Non-Small Cell Lung Cancer? Available from:
2 American Cancer Society. Targeted Drug Therapy for Non-Small Cell Lung Cancer. Available from:
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. 5, 69 (2021).
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

Foundation Medicine:
Erin Smith, 262-914-2779

Source: Foundation Medicine

June 10, 2022