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Lynparza EU CHMP opinion in pancreatic cancer
Lynparza EU CHMP opinion in pancreatic cancer.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n RNS Number : 5008O\n AstraZeneca PLC\n 01 June 2020\n \n \n \n 1 June 2020 07:00 BST\n \n \n \n Lynparza\n \n \n recommended for approval in EU by CHMP for\n \n \n \n BRCA-mutated metastatic pancreatic cancer\n \n \n Only PARP inhibitor to demonstrate patient benefit in a Phase III trial in this setting\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 recommended for marketing authorisation in the European Union (EU) for the 1st-line maintenance treatment of patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer.\n \n The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the Phase III POLO trial, which were published in The New England Journal of Medicine.\n \n The 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 POLO trial was consistent with previous trials.\n \n José Baselga, Executive Vice President, Oncology R&D, said: \"Patients with advanced pancreatic cancer have seen limited treatment advances over the last few decades. We are now one step closer to bringing the first targeted medicine to certain biomarker-selected patients with advanced pancreatic cancer in the EU.\"\n \n Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: \"A pancreatic cancer diagnosis is devastating, and we are committed to research that aims to change the prognosis for patients. The POLO Phase III trial demonstrated that treatment with Lynparza extended time without disease progression in certain patients with advanced pancreatic cancer - we are hopeful that we will be able to bring this treatment to patients in the EU soon.\"\n \n The CHMP recommendation is for maintenance treatment with Lynparza for adult patients with germline BRCA1/2 mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment with...