(RTTNews) - AstraZeneca Plc. (AZN.L, AZN) said that its Imfinzi (durvalumab) has been recommended for marketing authorization in the European Union for the 1st-line treatment of adult patients with unresectable or metastatic biliary tract cancer in combination with chemotherapy (gemcitabine plus cisplatin). The CHMP positive opinion was based on results from the TOPAZ-1 Phase III trial.
The 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.
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