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LYNPARZA APPROVED IN JAPAN FOR OVARIAN CANCER
LYNPARZA APPROVED IN JAPAN FOR OVARIAN CANCER.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 3164C AstraZeneca PLC 19 January 2018 \n\n19 January 2018 07:00 GMT\n \nLYNPARZA RECEIVES APPROVAL IN JAPAN FOR THE TREATMENT OF ADVANCED OVARIAN CANCER\n \nLynparza is the first PARP inhibitor approved in Japan\n \nLynparza tablets approved as maintenance treatment for women with platinum-sensitive relapsed ovarian cancer regardless of BRCA mutation status\nAstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US (known as MSD outside the US and Canada) today announced that the Japanese Ministry of Health, Labour and Welfare has approved Lynparza (olaparib) tablets (300mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed ovarian cancer, regardless of their BRCA mutation status, who responded to their last platinum-based chemotherapy. Lynparza is the first poly ADP-ribose polymerase (PARP) inhibitor to be approved in Japan.\nDave Fredrickson, Executive Vice President, Head of the Oncology Business Unit at AstraZeneca, said: \"We are proud to bring this important first-in-class treatment to women with platinum-sensitive relapsed ovarian cancer in Japan who currently have very few treatment options. The trials show that with Lynparza maintenance therapy, women with ovarian cancer can live longer without their disease worsening and Lynparza is well tolerated.\"\nRoy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: \"Today's decision is significant for Lynparza and, more importantly, for Japanese patients living with advanced ovarian cancer. Our global collaboration with AstraZeneca reinforces how our joint efforts can advance science for patients, and we look forward to working together to explore the potential of Lynparza across multiple tumour types.\"\nThe approval was granted on the basis of two randomised trials of Lynparza maintenance therapy for platinum-sensitive relapsed ovarian cancer, SOLO-2 and Study 19. \nTable 1. Summary of key efficacy results from randomised trials:\n\n\n\n\nAnalysis\n\n\nReduction in the risk of disease progression or death (PFS)\n\n\nReduction in the risk of death (OS)\n\n\n\n\nSOLO-2\n[gBRCAm]\nn=295\n\n\nLynparza\n\n\n70% (HR 0.30 [95% CI, 0.22-0.41], P<0.0001; median 19.1 vs 5.5 months by investigator-assessed analysis)\n\n\nData...