NEW YORK – The US Food and Drug Administration on Tuesday 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 Merck and AstraZeneca's PARP inhibitor Lynparza (olaparib) plus hormone therapy.
Lynparza is approved in the US in combination with Zytiga (abiraterone) and prednisone or prednisolone for BRCA1/2-mutated metastatic castration-resistant prostate cancer (mCRPC). Single-agent Lynparza is approved for mCRPC patients who've progressed following prior hormone therapy and who have deleterious or suspected germline or somatic homologous recombination repair (HRR) gene mutations, including in BRCA1/2 and ATM.
The FDA previously approved both FoundationOne CDx and FoundationOne Liquid as companion tests for identifying mCRPC patients eligible for single-agent Lynparza. In the case of the tissue-based FoundationOne CDx, the agency approved it for identifying mCRPC patients with HRR gene alterations and approved the blood-based FoundationOne Liquid for identifying patients with deleterious or suspected deleterious BRCA1/2 or ATM alterations. The latest approval adds a new companion diagnostic indication to these tests' labels, allowing them to be used to identify mCRPC patients with BRCA1/2 mutations who are likely to benefit from the combination of Lynparza plus Janssen's Zytiga and a steroid.