European Commission approves Lynparza to treat germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer.- AstraZeneca + Merck Inc.

AstraZeneca and MSD Inc. announced that Lynparza (olaparib) has been approved in the European Union (EU) for patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer Pancreatic cancer is a rare, life-threatening disease with the lowest survival rate among the most common cancers.

Approximately 5-7% of patients with metastatic pancreatic cancer have a germline BRCA mutation. The approval by the European Commission was based on results from the Phase III POLO trial, which were published in The New England Journal of Medicine. It follows the recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency.

The POLO trial demonstrated that Lynparza nearly doubled the time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months versus 3.8 months on placebo. The safety and tolerability profile of Lynparza in the trial was consistent with previous trials.