FDA has approved Foundation Medicine, approval to market FoundationOne CDx and FoundationOne Liquid CDx as companion diagnostics for AstraZeneca and Merck’s Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for treating adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC).
This decision 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.
Mia Levy, CMO at Foundation Medicine, acknowledged FDA approval for Olaparib Plus Abiraterone and highlighted the importance of genomic mutation testing in metastatic diagnosis.
She emphasized that Foundation Medicine’s high-quality tissue and liquid biopsy tests would improve patient access to genomic testing and simplify treatment decisions.
Olaparib Plus Abiraterone addressed a critical need for first-line treatment options for BRCA-mutated metastatic castration-resistant prostate cancer patients.
Courtney Bugler, President and CEO of ZERO Prostate Cancer, acknowledged the FDA approval as a significant milestone for men with aggressive prostate cancer.
She emphasized the importance of biomarker testing in personalized treatment and praised Foundation Medicine for its additional companion diagnostic indications.
Foundation Medicine had 7 FDA-approved prostate cancer diagnostics, led globally in approvals, and held 60% of U.S. NGS testing approvals.
Source: 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
https://www.foundationmedicine.com/press-release/fda-approval-cdxs-lynparza-brca-mcrpc
