![]() Now a major clinical challenge is identifying the population of patients with wild-type BRCA1/2 who nonetheless will benefit from PARP inhibition. Germline testing for BRCA1/2 mutations has been available since the 1990s and is used both to assess breast and ovarian cancer risk and to guide use of PARP inhibitors in patients with cancer. 2 The FDA approved the first PARP inhibitor, olaparib (Lynparza), in 2014 for patients with germline BRCA1/2 mutations who have heavily pretreated advanced ovarian cancer, 3 and the agency has since broadened indications for this class of agents in terms of disease settings and biomarker status. ![]() Tumors with mutations in BRCA1 and BRCA2, breast cancer susceptibility genes that are quintessential members of the homologous recombination repair (HRR) pathway, are highly sensitive to platinum-based chemotherapy and PARP inhibitors. Homologous recombination, one of the major mechanisms of defective DNA repair, has emerged as a bona fide therapeutic target, yet its optimal use as a biomarker for patient selection remains a clouded scientific question.
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