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FDA Priority Review for Lynparza in breast cancer
FDA Priority Review for Lynparza in breast cancer.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 8809T AstraZeneca PLC 18 October 2017 \n\n18 October 2017 07:00 BST\n \nUS FDA ACCEPTS REGULATORY SUBMISSION FOR \nLYNPARZA IN METASTATIC BREAST CANCER AND \nGRANTS PRIORITY REVIEW\n \nLynparza has the potential to offer a new treatment option for patients with germline BRCA-mutated, HER2-negative metastatic breast cancer\n \nRegulatory submission acceptance is first for a PARP inhibitor beyond ovarian cancer\n \n \nAstraZeneca and Merck & Co., Inc., (Merck: known as MSD outside the US and Canada) today announced that the US Food and Drug Administration (FDA) has accepted and granted priority review for a supplemental New Drug Application (sNDA) for the use of Lynparza (olaparib) tablets in patients with germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic settings. A Prescription Drug User Fee Act date is set for the first quarter of 2018.\n \nThis is the first submission for a poly ADP-ribose polymerase (PARP) inhibitor outside ovarian cancer and the third indication submission for Lynparza in the US. The sNDA is based on the positive results from the Phase III OlympiAD trial published in the New England Journal of Medicine.\n \nLynparza was first approved in December 2014 as a capsule formulation, making it the first ever PARP inhibitor to be approved. Since then, Lynparza has been used to treat more than 3,000 advanced ovarian cancer patients. Lynparza tablets are currently being tested in a range of tumour types including breast, 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 potentia...