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Imfinzi approved in EU for biliary tract cancer
Imfinzi approved in EU for biliary tract cancer.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n 21 December 2022 07:00 GMT\n \n \n \n \n \n \n Imfinzi\n \n \n plus chemotherapy approved in the EU as first immunotherapy\n \n \n \n \n regimen for patients with advanced biliary tract cancer\n \n \n \n \n \n \n Approval based on TOPAZ-1 updated survival results showing Imfinzi\n \n \n combination reduced risk of death by 24% vs. chemotherapy alone\n \n \n \n \n \n AstraZeneca's Imfinzi (durvalumab) has been approved in the European Union (EU) for the 1st-line treatment of adult patients with unresectable or metastatic biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine plus cisplatin).\n \n \n \n \n \n The approval by the European Commission was based on the primary results from the\n TOPAZ-1\n Phase III trial published in the\n \n New England Journal of Medicine Evidence\n \n ,\n and on the updated results presented at the\n \n European Society for Medical Oncology Congress 2022\n \n . The approval follows the\n \n recommendation\n \n by The Committee for Medicinal Products for Human Use of the European Medicines Agency in November 2022.\n \n \n \n \n \n At the\n \n interim analysis\n \n , Imfinzi plus chemotherapy reduced the risk of death by 20% versus chemotherapy alone (based on a hazard ratio [HR] of 0.80; 95% confidence interval [CI] 0.66-0.97; p=0.021).\n Updated results\n from TOPAZ-1 after an additional 6.5 months of follow-up showed a 24% reduction in the risk of death versus chemotherapy alone (HR 0.76; 95% CI, 0.64-0.91), with more than two times as many patients treated with Imfinzi plus chemotherapy estimated to be alive at two years versus chemotherapy alone (23.6% versus 11.5%). Updated median overall survival (OS) was 12.9 months versus 11.3 with chemotherapy.\n \n \n \n \n \n BTC is a group of rare and aggressive cancers that occur in the bile ducts (cholangiocarcinoma) and gallbladder.1,2 There are approximately 211,000 new patients diagnosed with gallbladder and biliary tract cancer each year, and about 40,000 of these occur across Europe.3 These patients have a poor prognosis, with approximately 5% to 15% of patients with BTC surviving five years.4\n \n \n \n \n \n Juan W. Valle, MD, Professor of Medical Oncology at the University of Manchester and The Christie NHS Foundation Trust, UK, and a lead investigator in the TOPAZ-1 Phas...