FDA Approves Olaparib for First-Line Maintenance of BRCA-Mutated, Advanced Ovarian Cancer
Posted: Thursday, December 20, 2018
On December 19, 2018, the U.S. Food and Drug Administration (FDA) approved the PARP inhibitor olaparib (Lynparza) 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 germline BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer should be selected for therapy based on an FDA-approved companion diagnostic.
Approval was based on the SOLO-1 trial (ClinicalTrials.gov identifier NCT01844986), a randomized, double-blind, placebo-controlled, multicenter trial that compared the efficacy of olaparib with placebo in patients with BRCA-mutated advanced ovarian, fallopian tube, or primary peritoneal cancer after first-line platinum-based chemotherapy. Patients were randomly assigned to receive olaparib tablets at 300 mg orally twice daily (n = 260) or placebo (n = 131).
The trial demonstrated a statistically significant improvement in investigator-assessed progression-free survival for olaparib compared with placebo. The estimated median progression-free survival was not reached in the olaparib arm and was 13.8 months in the placebo arm.
The most common adverse reactions of any grade occurring in patients who received olaparib in the SOLO-1 trial were nausea, fatigue, abdominal pain, vomiting, anemia, diarrhea, upper respiratory tract infection/influenza/nasopharyngitis/bronchitis, constipation, dysgeusia, decreased appetite, dizziness, neutropenia, dyspepsia, dyspnea, urinary tract infection, leukopenia, thrombocytopenia, and stomatitis.
The FDA also approved BRACAnalysis CDx to be used by health-care professionals to identify patients with advanced ovarian cancer who have a germline BRCA mutation and are eligible for olaparib following response to platinum-based chemotherapy. The effectiveness of the BRACAnalysis CDx test was based on the SOLO-1 trial population, for whom deleterious or suspected deleterious germline BRCA-mutant status was confirmed with either prospective or retrospective testing with the BRACAnalysis CDx test.