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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