The US Food and Drug Administration (FDA) approved olaparib as maintenance therapy for women with recurrent, epithelial ovarian, fallopian tube or primary peritoneal cancer responsive to platinum-based chemotherapy regardless of BRCA status, and also granted approval for use in patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have progressed after 3 or more lines of chemotherapy.
The FDA based its approvals on data collected from 2 clinical trials.
In the phase 3 SOLO-2 trial (ClinicalTrials.gov Identifier: NCT01874353) patients received oral olaparib 300 mg tablets alone twice daily for maintenance therapy of BRCA-mutation positive relapsed ovarian cancer.
Patients in the olaparib arm experienced a 70% reduction in the risk of disease progression or death (hazard ratio [HR], 0.30; 95% CI, 0.22-0.41; P <.0001) vs placebo. Patients also achieved progression-free survival (PFS) of 19.1 months in the olaparib arm vs 5.5 months in the placebo arm.
In Study 19, researchers assigned 265 patients with advanced, relapsed ovarian cancer to receive oral olaparib 400 mg twice daily vs placebo as maintenance therapy.
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Patients who received olaparib experienced a reduced risk of disease progression or death by 65%, and an improved PFS of 8.4 months vs 4.8 months for placebo regardless of BRCA status (HR, 0.35; 95% CI, 0.25-0.49; P <.0001). Patients in the olaparib arm also had a median overall survival (OS) of 29.8 months vs 27.8 months for patients in the placebo arm (HR, 0.73; 95% CI, 0.55-0.95).
An approval for a tablet formulation accompanied the FDA approval for expanded use.
- Lynparza (olaparib) receives additional FDA approval in the US for ovarian cancer [news release]. Wilmington, DE: AstraZeneca; August 17, 2017. http://www.businesswire.com/news/home/20170817006014/en/LYNPARZA%C2%AE-olaparib-Receives-Additional-FDA-Approval-Ovarian. Accessed August 18, 2017.