As­traZeneca ex­pands its block­buster Imfinzi fran­chise with new ap­proval in bil­iary tract can­cer

Dubbed the first im­munother­a­py for pa­tients with ad­vanced bil­iary tract can­cer — the FDA on Fri­day ap­proved As­traZeneca’s PD-L1 Imfinzi in com­bo with gem­c­itabine and cis­platin for the new can­cer in­di­ca­tion.

The ap­proval was based on a dou­ble-blind, place­bo-con­trolled Phase III tri­al of 685 pa­tients that found a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in OS of 12.8 months (95% CI: 11.1, 14) in the dur­val­um­ab arm ver­sus 11.5 months (95% CI: 10.1, 12.5) in the place­bo plus chemo arm, ac­cord­ing to the re­sults pub­lished in the New Eng­land Jour­nal of Med­i­cine in June.

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