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Lynparza approved in the EU for 1st-line
Lynparza approved in the EU for 1st-line.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 5405C AstraZeneca PLC 18 June 2019 \n\n18 June 2019 07:00 BST\n \nLynparza approved in the EU for 1st-line maintenance\ntreatment of BRCA-mutated advanced ovarian cancer\n \n60% of patients receiving Lynparza remained free of disease progression\nafter three years vs. 27% on placebo in pivotal Phase III SOLO-1 trial\n \nAstraZeneca and MSD's Lynparza is the only PARP\ninhibitor approved in the EU for this indication\n\nAstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced that the European Commission (EC) has approved Lynparza (olaparib) as a 1st-line maintenance treatment for women with BRCA-mutated advanced ovarian cancer.\n \nThe licensed indication is as a maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of 1st-line platinum-based chemotherapy.\n \nDave Fredrickson, Executive Vice President, Oncology Business Unit, said: \"This approval sets the stage for a new standard of care in the EU for women with ovarian cancer and a BRCA mutation. The goals of front-line therapy have always been long-term remission and even cure, yet currently 70% of patients relapse within three years of initial treatment. The progression-free survival benefit of Lynparza observed in SOLO-1 represents a major step forward in our ambition to help transform patient outcomes.\"\n \nRoy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: \"In SOLO-1, Lynparza demonstrated clinically-meaningful results with a 70% reduction in the risk of disease progression or death in the first-line maintenance treatment of patients with BRCAm advanced ovarian cancer. Merck and AstraZeneca are committed to improving outcomes for people with cancer and we will work to bring this new option to women in the EU, many of whom have historically poor outcomes, as quickly as possible.\"\n \nThe EC approval was based on data from the pivotal Phase III SOLO-1 trial which tested Lynparza as maintenance monotherapy compared with placebo in patients with BRCAm ...