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FoundationOne®CDx Receives FDA-Approval as a Companion Diagnostic for VITRAKVI®(larotrectinib) to Identify Patients with NTRK Fusions Across All Solid Tumors

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Foundation Medicine, Inc. 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 VITRAKVI® (larotrectinib), which is currently FDA-approved for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. FoundationOne CDx, the only FDA-approved tissue-based comprehensive genomic profiling (CGP) test, is now approved to detect NTRK1/2/3 fusions across all solid tumor types and identify patients who may be appropriate for treatment with VITRAKVI.

NTRK fusion positive cancer occurs when a piece of the chromosome containing the NTRK gene breaks off and binds to another chromosome. These NTRK gene fusions produce TRK fusion proteins, which may cause cancer cells to grow.1NTRK fusions are more commonly found in rare cancer types, such as secretory carcinoma of the breast or salivary gland and infantile fibrosarcoma, but they can also occur across many more common cancer types including glioma, melanoma and carcinomas of the lung, thyroid and colon.2

“Taking a comprehensive and validated approach to genomic testing is critical for all advanced cancer patients, but especially for those harboring rare mutations that can be missed with alternative testing methods,” said Brian Alexander, M.D., M.P.H., chief medical officer at Foundation Medicine. “Not only will this approval improve access to genomic testing and reinforce the role it plays in rare cancers, but it also confirms the incredible progress made toward tumor-agnostic cancer care. We’re proud of the impact this will have on NTRK fusion positive cancer patients.”

FoundationOne CDx is the first FDA-approved broad companion diagnostic that is clinically and analytically validated for solid tumors. The tissue-based comprehensive genomic profiling test is currently approved as a companion diagnostic for more than 20 targeted therapies.

“Many patients with rare conditions, like NTRK fusion positive cancer have limited treatment options and poor access to targeted therapies,” said Susan Spinosa, co-chair and patient founder of the NTRKers. “This companion diagnostic approval is a critical step forward in addressing this challenge as it provides this patient population with broader access to comprehensive genomic testing and appropriate treatment options.”

The approval of VITRAKVI was based on data from three multicenter, open-label, single-arm clinical trials: LOXO-TRK-14001 (NCT02122913), SCOUT (NCT02637687), and NAVIGATE (NCT02576431). Identification of positive NTRK gene fusion status was prospectively determined in local laboratories using next generation sequencing (NGS) or fluorescence in situ hybridization (FISH). NTRK gene fusions were inferred in three pediatric patients with infantile fibrosarcoma who had a documented ETV6 translocation by FISH. The major efficacy outcome measures were overall response rate (ORR) and response duration, as determined by a blinded independent review committee according to RECIST 1.1. The clinical validation to support the FoundationOne CDx NTRK companion diagnostic approval was then achieved through a clinical bridging study between the local clinical trial assays and FoundationOne CDx.

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

Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patient’s cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicine’s molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. For more information, please visit or follow Foundation Medicine on Twitter (@FoundationATCG).

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

Vitrakvi® is a registered trademark of Bayer

Source: Foundation Medicine

1 National Cancer Institute. “NTRK Gene Fusion.”

2 “Annals of Oncology. “Identifying patients with NTRK fusion cancer”

Foundation Medicine:
Lee-Ann Murphy, 617-245-3077

Foundation Medicine:
Erin Smith, 262-914-2779

Source: Foundation Medicine

October 24, 2020