February 2019—Olaparib (Lynparza, AstraZeneca) has been approved by the FDA for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line, platinum-based chemotherapy. Patients with gBRCAm advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer should be selected for therapy based on an FDA-approved companion diagnostic.
The agency also approved the BRACAnalysis CDx test (Myriad Genetics) to identify patients with germline BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are eligible for olaparib.
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