PBR Staff Writer Published 29 March 2017
The US Food and Drug Administration (FDA) has accepted AstraZeneca’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 agency also granted priority review status with a Prescription Drug User Fee Act (PDUFA) set for third quarter of this year.
Lynparza tablets are an investigational formulation and are not FDA-approved for any use at present.
AstraZeneca oncology US medical affairs vice president Andrew Coop 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 US FDA filing acceptance shows how we are progressing the science behind lynparza – the first PARP inhibitor approved in the US more than two years ago – while also investigating Lynparza in other tumor types, including breast, pancreatic and prostate.”
AstraZeneca had filed the application based on the phase 3 trial findings which demonstrated Lynparza to have brought down the risk of disease progression by 70% in germline BRCA-mutated patients, in comparison with placebo.
Results from the Phase III SOLO-2 trial showed a significant improvement in progression-free survival (PFS) with Lynparza tablets, compared with placebo.
Lynparza is an oral poly ADP-ribose polymerase (PARP) inhibitor, that has been developed to exploit tumor DNA damage response (DDR) pathway deficiencies to selectively destroy cancer cells.
At present, Lynparza capsules (400mg twice daily) are approved in the US as a monotherapy in patients with deleterious or suspected deleterious germline BRCA-mutated (as identified by an FDA-approved test) advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy.
Image: AstraZeneca’s lynparza gets priority review designation from FDA. Photo: courtesy of AstraZeneca.