FDA Approves FoundationOne CDx and Liquid CDx for Lynparza with Abiraterone in BRCA-Mutated Prostate Cancer

Foundation Medicine, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved its tests, FoundationOne CDx and FoundationOne Liquid CDx, as companion diagnostics for the treatment of adult patients with BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC). These tests will be used to identify patients who could benefit from a combination therapy involving Lynparza (olaparib), abiraterone, and prednisone or prednisolone. This approval builds on previous endorsements for using FoundationOne CDx and FoundationOne Liquid CDx to identify other genetic alterations in mCRPC patients.

Prostate cancer ranks among the most prevalent cancers in men, with BRCA1- or BRCA2-mutated mCRPC being particularly aggressive. This specific form of the disease accounts for around 11% of all prostate cancer cases and presents significant treatment challenges, often resulting in a poor prognosis despite advancements in therapy options.

Mia Levy, M.D., Ph.D., Chief Medical Officer at Foundation Medicine, emphasized the importance of genomic testing at the metastatic diagnosis stage to guide treatment decisions. She noted that the company's tissue and liquid biopsy diagnostic tests would facilitate broader access to genomic testing and aid in making informed treatment decisions. Levy highlighted the critical need for first-line treatment options for patients with BRCA-mutated mCRPC, pointing out that this new combination therapy represents a significant advancement.

Foundation Medicine is unique in offering a comprehensive range of FDA-approved tissue and blood-based genomic profiling tests. The FoundationOne CDx test uses tissue samples to analyze over 300 cancer-related genes for genomic alterations, while FoundationOne Liquid CDx provides similar genomic insights using a blood sample. With the latest FDA approval, Foundation Medicine now holds seven companion diagnostic indications for prostate cancer, making it a leader in this field. The company boasts 60% of all U.S. companion diagnostic approvals for next-generation sequencing (NGS) testing.

Courtney Bugler, President and CEO of ZERO Prostate Cancer, recognized the milestone's significance for men battling aggressive prostate cancer. Bugler praised the role of biomarker testing in enabling personalized treatment decisions and commended Foundation Medicine for expanding its companion diagnostic indications.

Lynparza, the drug in question, is jointly developed and commercialized by AstraZeneca and Merck. Foundation Medicine and FoundationOne are registered trademarks of Foundation Medicine, Inc.

FoundationOne CDx is a next-generation sequencing-based diagnostic device that detects various genetic alterations in 324 genes and specific gene rearrangements. It is intended for use in identifying patients who may benefit from certain targeted therapies and offers tumor mutation profiling for use by qualified healthcare professionals. However, a negative test result does not rule out the presence of genetic alterations, and some patients may still need a biopsy.

Similarly, FoundationOne Liquid CDx is a qualitative next-generation sequencing-based test that analyzes 324 genes using cell-free DNA from blood samples. It is designed to identify patients who may benefit from specific therapies but does not guarantee a treatment match. Negative results should be followed up with tumor tissue testing to confirm genomic alteration status.

Both tests are prescription-based and intended for use by healthcare professionals to guide treatment decisions in oncology.

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