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Lynparza CHMP for ovarian cancer maintainance
Lynparza CHMP for ovarian cancer maintainance.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 8137F AstraZeneca PLC 23 February 2018 \n\nThis announcement contains inside information\n \n23 February 2018 12:30 BST\n \nLYNPARZA RECEIVES POSITIVE EU CHMP OPINION IN PLATINUM-SENSITIVE RELAPSED OVARIAN CANCER\nAstraZeneca and MSD's new Lynparza tablet formulation recommended for maintenance therapy regardless of BRCA status \nAstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US (known as MSD outside 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 a marketing authorisation of Lynparza (olaparib) tablets (300mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed high grade, epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy. Lynparza is recommended for treatment in this setting regardless of patients' BRCA mutation status. \n \nSean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: \"The data show that Lynparza provides long-term disease control, delaying the need for further chemotherapy for this broader group of women with platinum-sensitive relapsed ovarian cancer, irrespective of their BRCA status. It also offers a well-characterised safety and tolerability profile, which is critical to help enable patients to stay on treatment.\"\n \nRoy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: \"We welcome this positive opinion based upon data which indicate the potential impact for Lynparza as maintenance therapy for women with platinum-sensitive relapsed ovarian cancer. We look forward to our continued work with AstraZeneca to bring Lynparza to patients in the EU.\"\nThe CHMP recommendation is based on two randomised trials, SOLO-2 and Study 19, which showed Lynparza reduced the risk of disease progression or death for platinum-sensitive relapsed patients compared to placebo.\nSummary of key efficacy results from randomised trials:\n\n\n\n\nAnalysis\n\n\nSOLO-2\n[germline BRCA-mutated]\nn=295\n\n\nStudy 19\n[platinum-sensitive relapsed]\nn=265\n\n\n\n\nLynparza\n\n\nPlacebo\n\...