AstraZeneca’s Imfinzi+chemotherapy approved in E.U. in BTC patients

The company states: "AstraZeneca’s Imfinzi has been approved in the European Union for the 1st-line treatment of adult patients with unresectable or metastatic biliary tract cancer, BTC, in combination with chemotherapy. The approval by the European Commission was based on the primary results from the TOPAZ-1 Phase III trial published in the New England Journal of Medicine Evidence, and on the updated results presented at the European Society for Medical Oncology Congress 2022. The approval follows the recommendation by The Committee for Medicinal Products for Human Use of the European Medicines Agency in November 2022. At the interim analysis, Imfinziplus chemotherapy reduced the risk of death by 20% versus chemotherapy alone. Updated results from TOPAZ-1 after an additional 6.5 months of follow-up showed a 24% reduction in the risk of death versus chemotherapy alone, with more than two times as many patients treated with Imfinzi plus chemotherapy estimated to be alive at two years versus chemotherapy alone. Updated median overall survival was 12.9 months versus 11.3 with chemotherapy." Reference Link