FDA accepts Lynparza NDA for priority review

The US Food and Drug Administration has accepted the New Drug Application (NDA) for Lynparza (olaparib) tablets (300mg twice daily) for use in platinum-sensitive, relapsed ovarian cancer patients in the maintenance setting, says the drug’s maker AstraZeneca (LSE: AZN).

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%, compared with placebo in germline BRCA-mutated patients. SOLO-2 trial results were presented on March 14th at the Society of Gynecologic Oncology Annual Meeting on Women’s Cancer.

The NDA acceptance follows swiftly on the news that the FDA had granted faster-than-expected approval for US biotech firm Tesaro’ Zejula (niraparib) as maintenance treatment for patients with ovarian cancer. Analysts have forecast that 2022 sales of Zejula will reach $1.9 billion.