U.S. Food and Drug Administration Approves FoundationOne®CDx as a Companion Diagnostic for Janssen’s AKEEGA™ (niraparib and abiraterone acetate Dual Action Tablet) for Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer

Foundation Medicine’s tissue-based comprehensive genomic profiling test is now FDA approved to identify patients with metastatic castration-resistant prostate cancer harboring BRCA1- or BRCA2-positive mutations who may benefit from treatment with AKEEGA™

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^®CDx to be used as a companion diagnostic for Janssen Biotech, Inc. (Janssen’s) AKEEGA™ (niraparib and abiraterone acetate Dual Action Tablet), which was approved by the FDA for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (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 10-15% of diagnoses.^3,4 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.

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. The test currently has over 30 companion diagnostic indications. Foundation Medicine is the global leader in companion diagnostic approvals. The company also has 60% of all U.S. companion diagnostic approvals for next generation sequencing (NGS) testing.

“With such a rapidly evolving therapeutic landscape in prostate cancer, high-quality companion diagnostics are important tools to support oncologists in the development of personalized treatment plans for each unique patient,” said Mia Levy, MD, PhD, chief medical officer at Foundation Medicine. “This companion diagnostic specifically will help enable broader access to an important new therapy option in BRCA1/2+ mCRPC. We look forward to ongoing collaboration with Janssen to help bring more treatment options to patients facing a cancer diagnosis.”

“BRCA1- or BRCA2-mutated metastatic castration-resistant prostate cancer has had a devastating impact on so many men and their families,” said Shelby Moneer, VP Patient Programs and Education, ZERO Prostate Cancer. “We are so encouraged to see continued progress in advancing treatment options and diagnostics for this devastating condition.”

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 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 Twitter and LinkedIn.

Foundation Medicine^® and FoundationOne^® are registered trademarks of Foundation Medicine, Inc.
AKEEGA™ is a trademark of Janssen Biotech, Inc.

Source: Foundation Medicine

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¹ Cancer.net. (03/2023) “Prostate Cancer Statistics.” https://www.cancer.net/cancer-types/prostate-cancer/statistics#:~:text=Prostate%20cancer%20is%20the%20most,diagnosed%20cancer%20in%20the%20world.
² Castro E, Eeles R. The role of BRCA1 and BRCA2 in prostate cancer. Asian J Androl. 2012 May;14(3):409-14. doi: 10.1038/aja.2011.150. Epub 2012 Apr 23. PMID: 22522501; PMCID: PMC3720154.
³ Abida W, et al. Prospective Genomic Profiling of Prostate Cancer Across Disease States Reveals Germline and Somatic Alterations That May Affect Clinical Decision Making. JCO Precis Oncol. 2017;2017:PO.17.00029.
⁴ Shore N, et al. Systematic Literature Review of the Epidemiology of Advanced Prostate Cancer and Associated Homologous Recombination Repair Gene Alterations. The Journal of Urology. 2021;205(4):977–986. https://doi.org/10.1097/JU.0000000000001570

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