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Lynparza approved in the EU for pancreatic cancer
Lynparza approved in the EU for pancreatic cancer.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n RNS Number : 3706S\n AstraZeneca PLC\n 08 July 2020\n \n \n \n 8 July 2020 07:00 BST\n \n \n \n \n \n Lynparza\n \n \n approved in the EU for BRCA-\nmutated metastatic pancreatic cancer\n \n \n \n \n \n Only PARP inhibitor approved in this disease\n \n \n \n AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced that Lynparza (olaparib) has been approved in the European Union (EU) for patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer.\n \n Pancreatic cancer is a rare, life-threatening disease with the lowest survival rate among the most common cancers.1 Approximately 5-7% of patients with metastatic pancreatic cancer have a germline BRCA mutation.2\n \n 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.\n \n Hedy L. Kindler, Co-Principal Investigator of the POLO trial and Professor of Medicine, University of Chicago Medicine, said: \"Today's approval opens the door to a new era of biomarker-led care for patients with metastatic pancreatic cancer in the EU, which has the highest incidence of any region globally. Lynparza now provides clinicians with a targeted, well-tolerated treatment option for patients with germline BRCA-mutated metastatic pancreatic cancer.\"\n \n \n Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: \"\n Patients with metastatic pancreatic cancer historically have faced poor outcomes due to the aggressive nature of the disease and few treatment advances have been made over the last few decades. In the POLO trial, Lynparza nearly doubled median progression-free survival versus placebo after 1st-line chemotherapy for patients with germline BRCA-mutated metastatic pancreatic cancer. This approval underscores the importance of testing all patients for germline BRCA mutations at the time of diagnosis, as it will help inform personalised treatment options for patients\n in the EU.\"\n \n \n \n \n \n Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research...