Posted by Michael Wonder on 29 Mar 2017
AstraZeneca shares progress on Lynparza (olaparib) tablets in the US
28 March 2017 - FDA grants priority review for maintenance setting in ovarian cancer patients with PDUFA set for Q3 2017.
AstraZeneca today announced that the US FDA has accepted the company’s new drug application for Lynparza (olaparib) tablets (300 mg 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 set for third quarter 2017.
The application 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.SOLO-2 trial results were presented on March 14th at the Society of Gynecologic Oncology Annual Meeting on Women’s Cancer.
