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Lynparza gets broad FDA approval in ovarian cancer
Lynparza gets broad FDA approval in ovarian cancer.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 3479O AstraZeneca PLC 18 August 2017 \n\nThis announcement contains inside information\n \n18 August 2017 07:00 BST\n \nLYNPARZA RECEIVES ADDITIONAL AND BROAD\nAPPROVAL IN THE US FOR OVARIAN CANCER\n \nLynparza's new tablet formulation approved as maintenance treatment for women\nwith platinum-sensitive recurrent ovarian cancer regardless of BRCA-mutation status\n \nLynparza tablets also indicated in BRCA-mutated ovarian cancer beyond the third-line setting\n \nNewly-approved tablet formulation means improved patient convenience\n \nAstraZeneca and Merck & Co., Inc., (Merck: known as MSD outside the U.S. and Canada) today announced that the US Food and Drug Administration (FDA) has granted approval for the PARP inhibitor, Lynparza (olaparib), as follows:\n \n· New use of Lynparza as a maintenance treatment for recurrent, epithelial ovarian, fallopian tube or primary peritoneal adult cancer who are in response to platinum-based chemotherapy, regardless of BRCA status;\n· New use of Lynparza tablets (2 tablets twice daily) as opposed to capsules (8 capsules twice daily);\n· Lynparza tablets also now indicated (conversion from the current accelerated approval) for the use in patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy.\n \nSean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, AstraZeneca, said: \"Physicians have almost three years of clinical experience with Lynparza on the market and we are now pleased to bring this important medicine, in a new tablet formulation, to a broader group of women. Today's approvals validate more than 10 years of dedicated research behind Lynparza, the world's first PARP inhibitor, which now provides oncologists with the greater flexibility for use in terms of treatment settings. It builds on our recently-announced collaboration with Merck, which aims to further increase the number of treatment options available to patients.\"\n \nEric Pujade-Lauraine, Head of the Women Cancers and Clinical Research Department at Hôpitaux Universitaires Paris Centre, site Hôtel-Dieu, AP-HP and Principal Investigator o...