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FDA approves Lynparza for metastatic breast cancer
FDA approves Lynparza for metastatic breast cancer.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 7898B AstraZeneca PLC 12 January 2018 \n\n12 January 2018 16:10 GMT\n \nLYNPARZA APPROVED BY US FDA IN GERMLINE BRCA-MUTATED \nMETASTATIC BREAST CANCER \n \nLynparza is the first and only PARP inhibitor approved for use beyond ovarian cancer \n \nLynparza reduced the risk of disease progression or death by 42% \ncompared to standard of care chemotherapy\n \nAstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today announced that the US Food and Drug Administration (FDA) has approved Lynparza (olaparib), for use in patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor positive (HR+) breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Patients are selected for therapy based on an FDA-approved companion diagnostic from Myriad Genetics.\n \nDave Fredrickson, Executive Vice President, Head of the Oncology Business Unit, AstraZeneca, said: \"This new approval for Lynparza makes it the first and only PARP inhibitor approved in metastatic breast cancer, and the only PARP inhibitor approved beyond ovarian cancer. This is significant for breast cancer patients, as the identification of BRCA status, in addition to hormone receptor and HER2 status, becomes a potentially critical step in the management of their disease.\"\n \nRoy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, Merck Research Laboratories said: \"This additional approval for Lynparza represents an important advance for women with HER2-negative metastatic breast cancer with a germline BRCA mutation, which is a difficult-to-treat cancer. Moreover, this approval adds further impetus to our important collaboration with AstraZeneca in developing cancer therapies.\" \n \nThe approval was based on data from the randomised, open-label, Phase III OlympiAD trial which investigated Lynparza versus physician's choice of chemotherapy (capecitabine, eribulin, or vinorelbine). In the trial, Lynparza signi...