The FDA has approved olaparib (Lynparza) as a maintenance treatment for 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 frontline platinum-based chemotherapy, as approved by an FDA-approved companion diagnostic assay. This is the first approval for a PARP inhibitor in the first-line maintenance setting.
The agency also approved BRACAnalysis CDx®
to be used by healthcare professionals to identify patients with advanced ovarian cancer who have a germline BRCA
mutation and are eligible for first-line maintenance therapy with olaparib in this setting.
The olaparib approval is based off of findings from the phase III SOLO-1 trial, in which olaparib reduced the risk of disease progression or death by 70% in patients with BRCA
-mutant advanced ovarian cancer who were in complete or partial response to platinum-based chemotherapy (HR, 0.30; 95% CI, 0.23-0.41; P
<.0001) compared with placebo following platinum-based chemotherapy. Olaparib’s safety profile was consistent with previous trials.
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