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AZ and MSD rapidly advance Lynparza in Japan
AZ and MSD rapidly advance Lynparza in Japan.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 2987U AstraZeneca PLC 23 October 2017 \n\n23 October 2017 07:00 BST\n \nASTRAZENECA AND MSD RAPIDLY ADVANCE LYNPARZA \nIN JAPAN WITH A SECOND REGULATORY SUBMISSION\n \nPotential to offer a new treatment option for patients with\ngermline BRCA-mutated, HER2-negative metastatic breast cancer\n \nAstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US (known as MSD outside the US and Canada) today announced that they have submitted a new drug application (NDA) to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for the use of Lynparza (olaparib) tablets in unresectable or recurrent BRCA-mutated breast cancer, with a decision expected in the second half of 2018.\n \nThe Japan NDA is based on the positive results from the Phase III OlympiAD trial published in the New England Journal of Medicine.\n \nThis is the second NDA for Lynparza in Japan where the medicine is currently under review for use in ovarian cancer, with a PMDA decision for this indication anticipated in the first half of 2018.\n \nLynparza tablets are currently being tested in a range of tumour types in addition to ovarian and breast, including prostate and pancreatic cancers.\n \nAbout OlympiAD \nOlympiAD is a randomised, open-label, multicenter Phase III trial assessing the efficacy and safety of Lynparza tablets (300mg twice daily) compared to 'physician's choice' chemotherapy (capecitabine, vinorelbine, eribulin) in 302 patients with HER2-negative metastatic breast cancer with germline BRCA1 or BRCA2 mutations, which are predicted or suspected to be deleterious. The international trial was conducted in 19 countries across Europe, Asia, North America and South America.\nAbout Lynparza (olaparib)Lynparza was the first FDA-approved oral poly ADP-ribose polymerase (PARP) inhibitor that may exploit tumour DNA damage response (DDR)-pathway deficiencies to potentially kill cancer cells. Specifically, in vitro studies have shown that Lynparza-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes, resulting in DNA damage and cancer cell death.\nLynparza is the foundation of AstraZeneca's industry-leading portfolio of potential new medicines targeting DDR mechanisms in cancer cells.\n \nAbout Germline BRCA mutations\nBRCA1 and BRCA2 are h...