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Lynparza approved in EU for the treatment of germl
Lynparza approved in EU for the treatment of germl.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 6866V AstraZeneca PLC 10 April 2019 \n\n10 April 2019 07:00 BST \n \nLynparza approved in EU for the treatment of\ngermline BRCA-mutated HER2-negative advanced breast cancer\n \nAstraZeneca and MSD's Lynparza reduced the risk of disease\nprogression or death by 42% vs. chemotherapy in Phase III OlympiAD trial\n \nFirst PARP inhibitor approved in the EU for patients with this\ndifficult-to-treat disease and third EU approval for Lynparza\n \nAstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced the European Commission has approved Lynparza (olaparib) as a monotherapy for the treatment of adult patients with germline BRCA1/2-mutations (gBRCAm), and who have human epidermal growth factor receptor 2 (HER2)-negative locally-advanced or metastatic breast cancer.\n \nUnder the licensed indication, patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless they were unsuitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.\n \nDave Fredrickson, Executive Vice President, Oncology, said: \"With this approval, Lynparza provides patients throughout the EU with a targeted and oral chemotherapy-free treatment option for a difficult-to-treat cancer. It also reinforces the importance of testing for biomarkers including BRCA, hormone receptor and HER2 expression, helping physicians to make the most informed treatment decisions for patients.\"\n \nRoy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: \"In the OlympiAD trial, which supported this approval, Lynparza demonstrated a meaningful improvement in progression-free survival compared to chemotherapy in patients with germline BRCA-mutated metastatic breast cancer. We look forward to making this new option available across the EU, where we hope it will improve outcomes for many patients.\"\n \nThe approval was based on data from the randomised, open-label, Phase III OlympiAD trial which tested Lynparza vs. physician's choice of chemotherapy (capecitabine, eribulin, or...