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Imfinzi recommended for approval in the EU for BTC
Imfinzi recommended for approval in the EU for BTC.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n 14 November 2022 07:05 GMT\n \n \n \n \n \n \n Imfinzi\n \n \n plus chemotherapy recommended for approval in the EU by CHMP\n \n \n \n \n as first immunotherapy regimen for advanced biliary tract cancer\n \n \n \n \n \n \n Positive opinion based on TOPAZ-1 Phase III trial updated survival results showing\n \n \n Imfinzi combination reduced risk of death by 24% vs. chemotherapy alone\n \n \n \n \n \n AstraZeneca's Imfinzi (durvalumab) has been recommended for marketing authorisation 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 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion 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 , and on the updated results presented at the\n \n European Society for Medical Oncology Congress 2022\n \n .\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 (hazard ratio [HR] 0.80; 95% confidence interval [CI] 0.66-0.97; p=0.021).\n \n \n \n Updated results\n \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 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 and gallbladder.1,2 There are approximately 210,000 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, UK, and a lead investigator in the TOPAZ-1 Phase III trial, said: \"This positive opinion is welcome news for patients with advanced biliary tract cancer in the European U...