AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for Lynparza (olaparib) tablets (300mg twice daily) for use in platinum-sensitive, relapsed ovarian cancer patients in the maintenance setting.
The FDA has also granted priority review status with a Prescription Drug User Fee Act (PDUFA) set for third quarter 2017. The NDA submission includes the Lynparza Phase III SOLO-2 trial data, which showed a reduced risk of disease progression by 70 percent, compared with placebo in germline BRCA-mutated patients.1 SOLO-2 trial results were presented on March 14th at the Society of Gynecologic Oncology Annual Meeting on Women’s Cancer.
The FDA grants Priority Review to applications for medicines that treat serious conditions and, if approved, would provide a significant improvement in treatment, safety, or efficacy over existing therapies.2 For applications granted priority review, the FDA takes action within six months of submission, compared with the standard 10-month review timeline.
Andrew Coop, Vice President, US Medical Affairs, Oncology, at AstraZeneca, said: “If approved as a maintenance therapy for patients with advanced ovarian cancer, Lynparza tablets would help address the unmet medical need and limited treatment options for women living with this disease, and offer patients a potential reduced pill burden for Lynparza.
Additionally, the U.S. FDA filing acceptance shows how we are progressing the science behind Lynparza — the first PARP inhibitor approved in the U.S. more than two years ago — while also investigating Lynparza in other tumor types, including breast, pancreatic and prostate.”
Results from the Phase III SOLO-2 trial demonstrated a significant improvement in progression-free survival (PFS) with Lynparza tablets, compared with placebo.1 The trial met its primary endpoint of investigator-assessed PFS (HR 0.30; 95% CI 0.22-0.41; P<0.0001; median 19.1 months vs 5.5 months).
PFS as measured by Blinded Independent Central Review (BICR) evaluation, a pre-specified sensitivity analysis supporting the primary endpoint, demonstrated a median PFS of 30.2 months vs 5.5 months for placebo, representing an improvement of 24.7 months (HR 0.25; 95% CI 0.18-0.35; P<0.0001).1
The safety profile for patients treated with Lynparza tablets during the SOLO-2 trial was generally consistent to those observed with the currently approved capsule formulation.1,3 Grade ≥3 adverse events were reported in 36.9% of patients treated with Lynparza, and in 18.2% of patients who received placebo.1
Lynparza tablets are an investigational formulation and are not FDA-approved for any use at this time.3,4 Lynparza capsules (400mg twice daily) are currently approved in the U.S. as a monotherapy in patients with deleterious or suspected deleterious germline BRCA-mutated (as detected by an FDA-approved test) advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy.3
The indication is approved under accelerated approval, based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.3
More than 2,600 ovarian cancer patients have been treated with Lynparza capsules since it was approved in the U.S. in December 2014.5
1 Pujade-Lauraine E., Ledermann J., Penson R., et al., Treatment with olaparib monotherapy in the maintenance setting significantly improves progression-free survival in patients with platinum-sensitive relapsed ovarian cancer: Results from the Phase III SOLO2 Study. Presented at the Society of Gynecologic Oncology Annual Meeting on Women’s Cancer (SGO), March 12 – 15. National Harbor, Maryland.
2 US Food and Drug Administration. Priority Review. Available Online. Accessed March 2017.
3 Lynparza (olaparib) Prescribing Information. AstraZeneca Pharmaceuticals LP, Wilmington, DE.
5 Data on File, 3314404, AstraZeneca Pharmaceuticals LP.
(Source: Business Wire)