U.S. Food and Drug Administration Approves FoundationOne®CDx and FoundationOne®Liquid CDx as Companion Diagnostics for Lynparza® (olaparib) in Combination with Abiraterone for Patients with BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer

Foundation Medicine’s tissue and liquid biopsy tests can now be used to identify more patients who could benefit from Lynparza in combination with abiraterone

Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne^®CDx and FoundationOne^®Liquid 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). 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.

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.

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

About Foundation Medicine: Your Essential Partner in Cancer Care

Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research. We collaborate with a broad range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership. Our deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and empowers researchers to develop new medicines. Every day, we are driven to help our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, please visit us on www.FoundationMedicine.com and follow us on LinkedIn and X.

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 www.F1CDxLabel.com.

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 genomic alteration 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.

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¹ Cancer.net. Prostate Cancer: Statistics. Updated March 2023. Accessed August 19, 2024. https://www.cancer.net/cancer-types/prostate-cancer/statistics

² Castro E, Eeles R. The role of BRCA1 and BRCA2 in prostate cancer. Asian J Androl. 2012;14(3):409-414. https://doi.org/10.1038/aja.2011.150

³ Valsecchi AA, Dionisio R, Panepinto O, et al. Frequency of Germline and Somatic BRCA1 and BRCA2 Mutations in Prostate Cancer: An Updated Systematic Review and Meta-Analysis. Cancers. 2023; 15(9):2435. https://doi.org/10.3390/cancers15092435

⁴ Messina C, Cattrini C, Soldato D, et al. BRCA Mutations in Prostate Cancer: Prognostic and Predictive Implications. J Oncol. 2020;2020:4986365. Published 2020 Sep 7. https://doi.org/10.1155/2020/4986365

⁵ Data on File, Foundation Medicine, Inc. 2024

⁶ Data on File, Foundation Medicine, Inc., data as of March 2024

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