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Lynparza approved in Japan for BRCAm breast cancer
Lynparza approved in Japan for BRCAm breast cancer.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 1228T AstraZeneca PLC 02 July 2018 \n\n02 July 2018 07:00BST\n \nLynparza approved in Japan for BRCA-mutated metastatic breast cancer\n \nLynparza is the first and only PARP inhibitor approved for use beyond ovarian cancer\n \nSecond approval in Japan for AstraZeneca and MSD's Lynparza\n \nAstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today announced that Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has approved Lynparza (olaparib) tablets for use in patients with unresectable or recurrent BRCA-mutated (BRCAm), human epidermal growth factor receptor 2 (HER2) negative breast cancer who have received prior chemotherapy. Patients are selected for therapy based on an approved companion diagnostic.\n \nDave Fredrickson, Executive Vice President, Head of the Oncology Business Unit at AstraZeneca, said: \"Earlier this year, Lynparza became the first PARP inhibitor available in Japan for advanced ovarian cancer. Now patients in Japan with BRCA-mutated, metastatic breast cancer will also have the opportunity to benefit from Lynparza. This latest approval underlines our ongoing efforts to make Lynparza available across multiple cancers as quickly as possible to patients around the world.\" \n \nRoy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: \"Metastatic breast cancer is a complex disease with remaining unmet medical need. This approval is significant for breast cancer patients as the evaluation of BRCA mutations, in addition to hormone receptor and HER2 status, now becomes an important step in the management of the disease.\"\n \nThe approval is based on data from the randomised, open-label, Phase III OlympiAD trial, which tested Lynparza vs chemotherapy. Patients were selected for therapy based upon a confirmed BRCA mutation. In the trial, Lynparza significantly prolonged progression-free survival (PFS) compared with chemotherapy, reducing the risk of disease progression or death by 42% (HR 0.58; 95% CI 0.43-0.80; p=0.0009, median PFS was 7.0 months with Lynparza vs 4.2 months with chemotherapy).\n \nLynparza was generally well tolerated with the majority of adverse events (AEs) reported as mild to moderate with ...