FDA advisory panel backs Lynparza for 1st-line maintenance treatment of gBRCAm

The US Food and Drug Administration Oncologic Drugs Advisory Committee (ODAC) voted by a narrow margin of 7 to 5 in favor of recommending Lynparza (olaparib) as a first-line maintenance monotherapy for patients with germline BRCA-mutated (gBRCAm) metastatic adenocarcinoma of the pancreas, whose disease has not progressed following 1st-line platinum-based chemotherapy.

The drug is marketed by Anglo-Swedish pharma major AstraZeneca (LSE: AZN), whose shares edged up 9.8% to £74,50, in partnership with US giant Merck & Co (NYSE: MRK). In its current indications, Lynparza generated third-quarter 2019 sales of $327 million, up 94% year-on-year.

In August 2019, the FDA accepted the supplemental New Drug Application (sNDA) for Lynparza for this indication with Priority Review and set a Prescription Drug User Fee Act (PDUFA) date for the fourth quarter of 2019.