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US FDA approved Lynparza for pancreatic cancer
US FDA approved Lynparza for pancreatic cancer.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 2291Y AstraZeneca PLC 30 December 2019 \n\n30 December 2019 07:00 GMT\n \nLynparza approved in the US as a 1st-line maintenance treatment\nof germline BRCA-mutated metastatic pancreatic cancer\n \nLynparza reduced the risk of disease progression or death by 47% in patients\nwhose disease had not progressed on at least 16 weeks of a 1st-line platinum-based chemotherapy regimen\n \nOnly PARP inhibitor approved in germline BRCA-mutated\nmetastatic pancreatic cancer\n \nAstraZeneca 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 US for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma (pancreatic cancer) whose disease has not progressed on at least 16 weeks of a 1st-line platinum-based chemotherapy regimen. Patients will be selected for therapy based on an FDA-approved companion diagnostic for Lynparza.\n \nThe approval follows the recommendation from the US FDA Oncologic Drugs Advisory Committee (ODAC) on 17 December for Lynparza in this indication, and was based on results from the pivotal Phase III POLO trial published in The New England Journal of Medicine and presented at the 2019 American Society of Clinical Oncology Annual Meeting.\n \nResults showed a statistically significant and clinically meaningful improvement in progression-free survival, where Lynparza nearly doubled the time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months vs. 3.8 months on placebo. The safety and tolerability profile of Lynparza in the POLO trial was in line with that observed in prior clinical trials.\n \nDave Fredrickson, Executive Vice President, Oncology Business Unit, said: \"Patients with advanced pancreatic cancer historically have faced poor outcomes due to the aggressive nature of the disease and limited treatment advances over the last few decades. Lynparza is now the only approved targeted medicine in biomarker-selected patients with advanced pancreatic cancer.\"\n \nRoy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research L...