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Foundation Medicine Expands Indication for FoundationOne®Liquid CDx to be used as a Companion Diagnostic for LYNPARZA®

Foundation Medicine’s pan tumor liquid biopsy test is now FDA-Approved to identify patients with BRCA1, BRCA2 and/or ATM alterations in metastatic castration-resistant prostate cancer who may be appropriate for treatment with LYNPARZA

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®Liquid CDx to be used as a companion diagnostic for LYNPARZA® (olaparib). As a companion diagnostic, FoundationOne Liquid CDx will use a blood-based biopsy to identify patients with BRCA1, BRCA2 and/or ATM alterations in metastatic castration-resistant prostate cancer (mCRPC) who may be appropriate for treatment with LYNPARZA. FoundationOne Liquid CDx, Foundation Medicine’s liquid biopsy test was approved by the FDA in August to report genomic alteration results for patients with any solid tumor.

Prostate cancer is the second most common cancer in men globally and despite progress made toward new treatment modalities, the mortality rate for this condition remains high.[1] Of critical importance is ensuring metastatic prostate cancer patients receive comprehensive genomic profiling (CGP) via liquid or tissue-based biopsies to determine eligibility for new targeted treatment options like LYNPARZA. Foundation Medicine’s tissue-based comprehensive genomic profiling test, FoundationOne®CDx, was approved as a companion diagnostic for LYNPARZA in May 2020.

“With this latest companion diagnostic approval, physicians now have the option to choose either tissue or liquid-based comprehensive genomic testing based on their patients’ need and condition. Since tissue availability can be an issue for some metastatic prostate cancer patients, blood-based testing is an important option to consider and critically important for informing patient care,” said Brian Alexander, M.D., M.P.H., chief medical officer at Foundation Medicine. “The approval of this companion diagnostic will allow more patients to access genomic testing, regardless of specimen type, and provide oncologists with another tool to guide personalized treatment decisions.”

Using a blood sample, FoundationOne Liquid CDx analyzes over 300 cancer-related genes for genomic alterations. The CGP test is now approved as a companion diagnostic for seven targeted therapies across four tumor types.

LYNPARZA was approved for mCRPC patients who carry mutations in homologous recombination repair (HRR) genes, based on the PROfound study, which was supported by Foundation Medicine and was the first positive phase III biomarker-selected study using a molecularly targeted treatment in men with mCRPC. The PROfound trial is the largest prospective Phase III study to date performing central tissue testing for HRR gene mutations in mCRPC patients. LYNPARZA is jointly developed and commercialized by AstraZeneca (LSE/STO/Nasdaq: AZN) and Merck & Co., Inc.

As a laboratory professional service which has not been reviewed or approved by the FDA, the FoundationOne Liquid CDx report delivers information about the genomic signatures microsatellite instability (MSI) and blood tumor mutational burden (bTMB), as well as single gene alterations, including NTRK fusions, to help inform the use of other therapies including immunotherapies. Also, as a laboratory professional service, the report provides relevant clinical trial information and includes interpretive content developed in accordance with professional guidelines in oncology for patients with any solid tumor.

About FoundationOne Liquid CDx

FoundationOne Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. 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. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.

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 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 www.FoundationMedicine.com or follow Foundation Medicine on Twitter (@FoundationATCG).

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

Source: Foundation Medicine

1. Bray et al. (2018). Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians, 68(6), pp.394-424.

Foundation Medicine Contact:

Lee-Ann Murphy, 617-245-3077
pr@foundationmedicine.com

Erin Smith, 262-914-2779
pr@foundationmedicine.com

Source: Foundation Medicine

November 10, 2020