FDA Approves FoundationOne®Liquid CDx for BRCA-Positive Metastatic Prostate Cancer

Foundation Medicine, Inc. has announced that its FoundationOne®Liquid CDx test has received approval from the U.S. Food and Drug Administration (FDA) to be used as a companion diagnostic for AKEEGA® (niraparib and abiraterone acetate) from Janssen Biotech, Inc., a Johnson & Johnson company. AKEEGA® is the first dual-action tablet approved by the FDA, combining PARP inhibition and hormone therapy, aimed at treating adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC). This approval follows the earlier approval of FoundationOne®CDx, Foundation Medicine’s tissue-based test, for the same therapy and indication in August 2023.

Prostate cancer ranks among the most common cancers in men, with BRCA1- or BRCA2-mutated mCRPC being notably aggressive. This form of the disease occurs in about 11% of prostate cancer diagnoses. Despite advancements in treatment, BRCA1- and BRCA2-mutated mCRPC remains a significant challenge, often yielding poor prognoses for patients.

BRCA1 and BRCA2 mutations in prostate cancer can be either germline or somatic, with somatic mutations being more prevalent. Tumor tissue testing is the preferred method for identifying these mutations. However, not all patients with mCRPC possess sufficient tumor tissue for such testing. The new FDA approval allows healthcare providers to utilize a liquid biopsy, which is minimally invasive, to identify more patients with BRCA mutations who might benefit from AKEEGA®.

Dr. Mia Levy, the Chief Medical Officer at Foundation Medicine, highlighted the importance of liquid biopsy in advanced cancers like mCRPC, where obtaining tissue samples can be difficult. She stated that the approval of the liquid biopsy test, alongside the existing tissue biopsy test, would broaden patient access to AKEEGA®. Dr. Levy emphasized that the capability to use both liquid-based and tissue-based tests ensures that healthcare providers have precise genomic information to make informed treatment decisions.

FoundationOne Liquid CDx, through a simple blood sample, examines over 300 cancer-related genes to provide genomic insights. The test already has several companion diagnostic indications for various cancers, including non-small cell lung cancer (NSCLC), prostate cancer, breast cancer, and colorectal cancer. With this latest approval, Foundation Medicine becomes the only company with five FDA-approved companion diagnostic indications specifically for prostate cancer. The company holds 60% of all U.S. companion diagnostic approvals for next-generation sequencing (NGS) testing, positioning it as a leader in the field.

Courtney Bugler, President and CEO of ZERO Prostate Cancer, commended Foundation Medicine’s liquid biopsy test, noting that it provides patients and their families with more tools to potentially extend and improve their quality of life.

Foundation Medicine is a pioneer in molecular profiling for cancer, dedicating its efforts to advancing clinical care and research. The company collaborates with a broad spectrum of partners within the cancer community, aiming to set the benchmark for quality and scientific excellence. Their expertise in cancer biology assists physicians in making informed treatment decisions and supports researchers in developing new therapies, ultimately striving to deliver precision cancer care to more people globally.

FoundationOne®CDx is a next-generation sequencing-based in vitro diagnostic device that detects various genetic alterations using DNA from tumor tissue specimens. It serves as a companion diagnostic to identify patients who may benefit from specific targeted therapies. FoundationOne®Liquid CDx, similarly, is an in vitro diagnostic test that analyzes circulating cell-free DNA from blood samples of advanced cancer patients to report genetic variants and guide treatment decisions. Both tests are for prescription use only and are intended to aid healthcare professionals in tailoring cancer treatments.