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Lynparza receives positive EU CHMP opinion for 1st
Lynparza receives positive EU CHMP opinion for 1st.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 3645X AstraZeneca PLC 29 April 2019 \n\n29 April 2019 07:00 BST\n \nLynparza receives positive EU CHMP opinion for 1st-line\nmaintenance treatment of BRCA-mutated advanced ovarian cancer\n \nAstraZeneca and MSD's Lynparza is the only PARP inhibitor to demonstrate\nan improvement in progression-free survival for patients in this setting\n\nAstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending Lynparza (olaparib) as a 1st-line maintenance treatment of BRCA-mutated advanced ovarian cancer.\nThe recommendation is for the use of Lynparza tablets 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 first-line platinum-based chemotherapy.\nDave Fredrickson, Executive Vice President, Oncology, said: \"There remains a significant unmet need in the treatment of advanced ovarian cancer as 70% of women globally relapse within the first three years after their initial treatment. The results of SOLO-1 demonstrate the potential of using Lynparza earlier in the treatment pathway as a maintenance therapy, and reinforce the importance of identifying a patient's BRCA mutation status as soon as they are diagnosed.\"\nRoy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: \"Women with advanced ovarian cancer need and deserve new treatment options. In the SOLO-1 trial, Lynparza demonstrated a significant progression-free survival benefit as maintenance treatment for patients with advanced BRCA-mutated ovarian cancer following response to first-line platinum-based chemotherapy. If approved, this expanded indication could change the way women in Europe with BRCA-mutated advanced ovarian cancer are treated.\"\n \nThe positive opinion is based on data from the pivotal Phase III SOLO-1 trial which showed that Lynparza reduced the risk of disease progression or death by 70% vs. placebo following resp...