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Foundation Medicine Secures FDA Approval for Tissue and Liquid NGS Companion Diagnostics for Lynparza Combination Therapy

NextEdge Admin

04 Sep 2024

2 min 5 sec

The US Food and Drug Administration (FDA) has approved Foundation Medicine's next-generation sequencing tests, FoundationOne CDx and FoundationOne Liquid CDx, for identifying patients with BRCA1/2-mutated prostate cancer who are eligible for treatment with Merck and AstraZeneca's PARP inhibitor, Lynparza (olaparib), in combination with hormone therapy. Specifically, Lynparza is approved in the US for use alongside Zytiga (abiraterone) and prednisone or prednisolone in treating BRCA1/2-mutated metastatic castration-resistant prostate cancer (mCRPC). Additionally, Lynparza is available as a single-agent therapy for mCRPC patients who have progressed following prior hormone therapy and who possess harmful or suspected germline or somatic homologous recombination repair (HRR) gene mutations, including BRCA1/2 and ATM.

Previously, the FDA approved both FoundationOne CDx and FoundationOne Liquid as companion diagnostics for identifying mCRPC patients eligible for single-agent Lynparza. The tissue-based FoundationOne CDx was approved to identify patients with HRR gene alterations, while the blood-based FoundationOne Liquid was approved for detecting deleterious or suspected deleterious BRCA1/2 or ATM alterations. The latest FDA approval expands the labels of these tests, allowing them to be used as companion diagnostics to identify mCRPC patients with BRCA1/2 mutations who are likely to benefit from the combination therapy of Lynparza, Zytiga, and a steroid, thereby offering a more tailored treatment approach for this patient population.