On August 14, 2023 Foundation Medicine Inc., reported that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneCDx 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) (Press release, Foundation Medicine, AUG 14, 2023, View Source [SID1234634409]).

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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 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.