On September 3, 2024 Foundation Medicine, Inc. reported that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneCDx and FoundationOneLiquid CDx to be used as companion diagnostics for AstraZeneca’s and Merck’s (known as MSD outside of the United States and Canada) Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC) (Press release, Foundation Medicine, SEP 3, 2024, View Source [SID1234646328]). This decision from the FDA follows the approval of FoundationOne CDx for Lynparza to identify mCRPC patients with homologous recombination repair (HRR) gene alterations and the approval of FoundationOne Liquid CDx for Lynparza to identify patients with BRCA1, BRCA2 and/or ATM alterations in mCRPC.
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Prostate cancer is one of the most common cancers in men.1 BRCA1- or BRCA2-mutated mCRPC is a particularly aggressive form of the disease,2 occurring in approximately 11% of diagnoses.3 Despite progress in developing new treatment options for this condition, BRCA1- or BRCA2-mutated mCRPC remains difficult to treat and patients often face a poor prognosis.4
"This approval reinforces the importance of testing for genomic mutations at metastatic diagnosis to help guide treatment decisions," said Mia Levy, M.D., Ph.D., chief medical officer at Foundation Medicine. "Our high-quality tissue and liquid biopsy companion diagnostic tests will allow more patients to access genomic testing, regardless of specimen type, and will simplify complex decisions by generating the best information to enable better decision-making. There is a critical unmet need for first-line treatment options for patients with BRCA-mutated metastatic castration-resistant prostate cancer and this combination therapy is an important advancement."
Foundation Medicine is the only company with an FDA-approved portfolio of tissue and blood-based comprehensive genomic profiling tests. Using a tissue sample, the FDA-approved FoundationOne CDx test analyzes more than 300 cancer-related genes for genomic alterations in a patient’s tumor. From a simple blood sample, FoundationOneLiquid CDx analyzes more than 300 cancer-related genes to provide genomic insights.
With today’s approval, Foundation Medicine is the only company that has seven FDA-approved companion diagnostic indications for prostate cancer.5 Foundation Medicine is the global leader in companion diagnostic approvals. The company has 60% of all U.S. companion diagnostic approvals for next-generation sequencing (NGS) testing.6
"This is an important milestone for men with aggressive prostate cancer," said Courtney Bugler, President and CEO of ZERO Prostate Cancer. "Biomarker testing is an important tool for patients and families to help facilitate personalized treatment decision making, and we applaud Foundation Medicine for these additional companion diagnostic indications."
Lynparza is jointly developed and commercialized by AstraZeneca and Merck.