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FDA panel backs Lynparza use for pancreatic cancer
FDA panel backs Lynparza use for pancreatic cancer.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 2333X AstraZeneca PLC 17 December 2019 \n\n17 December 2019 18:00 GMT\n \nLynparza recommended by FDA advisory committee for 1st-line maintenance treatment of germline BRCA-mutated metastatic pancreatic cancer\n \nODAC voted that Lynparza demonstrated a clinically meaningful and favourable\nrisk-benefit profile for patients based on Phase III POLO trial results\n \nAstraZeneca and MSD Inc., Kenilworth, NJ, US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 7 to 5 to recommend Lynparza (olaparib) as a 1st-line maintenance monotherapy for patients with germline BRCA-mutated (gBRCAm) metastatic adenocarcinoma of the pancreas (pancreatic cancer), whose disease has not progressed following 1st-line platinum-based chemotherapy.\n \nIn 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.\n \nJosé Baselga, Executive Vice President, Oncology R&D, said: \"We are pleased with the ODAC's recommendation for Lynparza and the potential to bring a personalised, biomarker-targeted medicine to patients with germline BRCA-mutated metastatic pancreatic cancer. 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. We look forward to working with the FDA as it completes the review of our application.\"\n \nRoy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: \"We are encouraged by the ODAC's favourable vote for Lynparza as a 1st-line maintenance therapy in germline BRCA-mutated metastatic pancreatic cancer. This recommendation is a significant step towards reaching our goal to help patients with this deadly disease.\"\n \nThe sNDA submission was based on the positive results from the Phase III POLO trial published in The New England Journal of Medicine and presented at the 2019 American Society of Clinical Oncology Annual Meeting. The results showed a statistically significant and clinically mea...