Foundation research

US FDA Approves Foundation Medicine’s FoundationOne®CDx as Companion Diagnostic for Roche’s Rozlytrek® (entrectinib)

F. Hoffmann-La Roche SA

  • FoundationOne CDx can now be used to identify patients with ROS1 fusion positive non-small cell lung cancer or patients with solid NTRK fusion positive tumors for whom a treatment with Rozlytrek may be appropriate

  • This approval marks the first and only companion diagnostic indication for Rozlytrekand another milestone in tumor-agnostic approaches for people with rare cancers

  • Roche is a leader in driving personalized healthcare worldwide through validated diagnostic tools, genomic insights and a continued focus on drug development

Basel, June 9, 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the United States Food and Drug Administration (US FDA) has approved Foundation Medicine’s FoundationOne®CDx as a companion diagnostic ( CDx) for Rozlytrek® from Roche (entrectinib). FoundationOne CDx is a comprehensive genomic profiling (PGC) pantumoral tissue biopsy test that assesses an individual’s cancer to identify the tumor’s unique molecular “fingerprint”. It is the first and only CDx approved by the US FDA to identify patients with ROS1 fusion positive non-small cell lung cancer (NSCLC) or patients with NTRK fusion positive cancers, for which treatment with Rozlytrek may be appropriate.

“The ability to tailor cancer therapies based on specific genomic alterations using validated whole genomic profiling (CGP) has transformed the traditional ‘one size fits all’ approach to cancer,” said Levi Garraway, MD. , Ph.D., Chief Medical Officer and Head of Global Product Development. “This approval marks a significant step forward in expanding treatment options and improving patient outcomes, especially those with rare tumors.”

Using CGP to identify genomic alterations associated with driving an individual’s cancer can help physicians make an informed treatment decision for the individual patient, potentially achieving better clinical outcomes.1

Rozlytrek is an approved targeted therapy to treat metastatic ROS1 fusion positive NSCLC and a drug agnostic for locally advanced or solid tumors that harbor NTRK fusions. ROS1 gene fusions account for 1-2% of NSCLC, the most common type of lung cancer that accounts for up to 85% of all diagnoses.2.3 NTRK gene fusions have been identified in a range of solid tumor types and are present in up to 90% of some rare cancer types and less than 1% of other more common cancers, including lung cancer and colorectal cancer.4

Approval is based on data from phase I ALKA-372-001 (EudraCT 2012-000148-88), phase I STARTRK-1 (NCT02097810) and phase II STARKTRK-2 (NCT02568267) tests. As a condition of this approval, Foundation Medicine will conduct a post-approval study powered by Flatiron Health-Foundation Medicine’s Clinicogenomic Database (CGDB) to further demonstrate the ability of FoundationOne CDx to identify patients with NSCLC with a mutation of ROS1 fusion for which treatment with Rozlytrek may be appropriate. The CGDB is an anonymized, HIPAA-compliant database that links results data from Flatiron’s oncology clinic network and genomic data from Foundation Medicine’s CGP tests. The database currently contains over 100,000 linked genomic profiles and continues to grow.

By combining tumor-agnostic drug development with data collection, high-quality diagnostics and the implementation of CGP, Roche is at the forefront of realizing personalized healthcare worldwide, enabling doctors to develop tailored treatment strategies for each individual and to enable smarter and more effective treatments. research and development to ensure no one is left behind.

About FoundationOne®CDx
FoundationOne CDx is a next-generation, sequencing-based in vitro diagnostic test for the detection of substitutions, insertion and deletion alterations (indels), and copy number changes in 324 genes and selected gene rearrangements, as well as genomic signatures, including microsatellite instability and tumor mutational load, using DNA isolated from paraffin-embedded and formalin-fixed tumor tissue samples. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic (CDx) to identify individuals who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. In addition, FoundationOne CDx is intended to provide tumor mutation profiling for use by qualified healthcare professionals in accordance with professional oncology guidelines for patients with solid malignant neoplasms. Use of the test does not guarantee that a patient will be matched to a treatment. A negative result does not exclude the presence of an alteration. Some patients may require a biopsy.

FoundationOne CDx was approved by the United States Food and Drug Administration in November 2017 and is currently approved as a CDx for 25 CDx indications and three group claims out of 30 targeted therapies. For a complete list of targeted therapies for which FoundationOne CDx is indicated as CDx, please visit

About Rozlytrek® (entrectinib)
Rozlytrek is an oral, once-daily, tumor-independent medication for the treatment of locally advanced or metastatic solid tumors that harbor NTRK1/2/3 or ROS1 gene fusions. It is a selective tyrosine kinase inhibitor designed to inhibit the kinase activity of TRKA/B/C and ROS1 proteins, whose activating fusions lead to proliferation in certain types of cancer. Rozlytrek can block the activity of NTRK and ROS1 kinases and can cause cancer cell death with NTRK or ROS1 gene fusions.

Rozlytrek is approved for the treatment of NTRK fusion solid tumors and ROS1 fusion non-small cell lung cancer by health authorities in more than 60 countries, including the United States Food and Drug Administration (US FDA), the Japanese Ministry of Health, Labor and Welfare (MHLW) and the European Medicines Agency (EMA). Prior to its approval, Rozlytrek was granted Breakthrough Therapy Designation by the US FDA, Sakigake Designation for Expedited Review by Japan’s MHLW, and Priority Drug Designation by the EMA.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded drugs, Roche has become the world’s largest biotechnology company and the world leader in in vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics to improve and save the lives of people around the world. We are a pioneer in personalized healthcare and want to further transform the way healthcare is delivered to have an even greater impact. To provide the best care for each person, we partner with many stakeholders and combine our strengths in diagnostics and pharmacy with insights from clinical practice.

In recognition of our efforts to pursue a long-term perspective in everything we do, Roche has been named one of the most sustainable companies in the pharmaceutical industry by the Dow Jones Sustainability Indexes for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare with local partners in all the countries where we work.

Genentech, in the United States, is a full member of the Roche group. Roche is the majority shareholder of Chugai Pharmaceutical, Japan.

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[1] Singal G, et al. Association of patient characteristics and tumor genomics with clinical outcomes in patients with non-small cell lung cancer using a clinicogenomics database. JAMA. 2019;321(14):1391–1399.
[2] Gainor JF, Shaw AT. New targets in non-small cell lung cancer: ROS1 and RET fusions. Oncologist. 2013; 18(7):865–75.
[3] The American Cancer Society. What is lung cancer? [Internet; cited Apr 2022]. Available from:
[4] Cocco E, Scaltriti M, Drilon A. NTRK fusion-positive cancers and TRK inhibitor therapy. Nat Rev Clin Oncol. 2018 Dec;15(12):731-747.

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