Foundation Medicine, Inc. 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. 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.
Source – Foundation Medicine