CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine, Inc. today announced that FoundationOneCDx has been approved by the U.S. Food and Drug Administration (FDA) for use as the companion diagnostic (CDx) to aid in identifying patients with non-small cell lung cancer (NSCLC) for whom treatment with Tabrecta (capmatinib) may be appropriate. Tabrecta is the first and only therapy approved by the FDA for adult patients with metastatic non-small cell lung cancer whose tumors have a mutation that leads to MET exon 14 skipping (METex14). This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). FoundationOne CDx is the only FDA-approved broad comprehensive genomic profiling (CGP) test for all solid tumors that incorporates multiple companion diagnostic claims. It is currently approved as the companion diagnostic test for 21 unique therapies.

NSCLC accounts for approximately 85% of lung cancer diagnoses,1 3 to 4% of which have MET exon 14 skipping.2 This milestone marks an important advancement for patients with METex14 mutated metastatic NSCLC, as there have previously been no treatment options available specifically for this diagnosis.

Because non-small cell lung cancer is a particularly aggressive and difficult to treat form of cancer, taking a comprehensive and validated approach to genomic testing is critical to help guide physicians treatment decisions, stated Foundation Medicines Chief Medical Officer Brian Alexander, M.D., M.P.H. FoundationOne CDx is a powerful tool for identifying patients with mutations that lead to MET exon 14 skipping who may be eligible for treatment with Tabrecta. This simultaneous therapy and companion diagnostic approval marks an important step forward in the treatment of rare cancer and demonstrates how deep collaboration across industry partners can advance patient care.

As part of the strategic collaboration with Novartis, which now includes two companion diagnostics for the Novartis portfolio of targeted oncology and immuno-oncology therapeutics, a companion diagnostic for Tabrecta is also in development for Foundation Medicines liquid biopsy assay.

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 http://www.foundationmedicine.com/genomic-testing/foundation-one-cdx.

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 patients cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicines 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 http://www.FoundationMedicine.com or follow Foundation Medicine on Twitter (@FoundationATCG).

Foundation Medicineand FoundationOne are registered trademarks of Foundation Medicine, Inc.

Tabrecta is a trademark of Novartis.

Source: Foundation Medicine

1 American Cancer Society. Key Statistics for Lung Cancer. Available at https://www.cancer.org/cancer/lung-cancer/about/what-is.html

2 Novartis Data on file. Novartis Calculation. Kantar Health. CancerMPact: lung (non-small cell) stage IV incidence and newly recurrent. Updated December 15, 2018. my.khapps.com.

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Foundation Medicine Receives FDA Approval for FoundationOneCDx as the Companion Diagnostic for Tabrecta (capmatinib), the Only FDA-Approved MET...