The company states: "AstraZeneca’s Imfinzi 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. The Committee for Medicinal Products for Human Use of the European Medicines Agency based its positive opinion 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. At the interim analysis, Imfinzi plus 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 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
Published first on TheFly
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