FDA grants priority review to Imfinzi with chemotherapy for advanced biliary tract cancer

The FDA granted priority review to durvalumab plus chemotherapy for treatment of locally advanced or metastatic biliary tract cancer.Durvalumab (Imfinzi, AstraZeneca) — a PD-L1 checkpoint inhibitor — is approved in the United States for treatment of patients with unresectable stage III non-small cell lung cancer whose disease has not progressed after chemoradiotherapy. It also is approved for treatment of extensive-stage small cell lung cancer.The FDA based priority review of the biliary tract cancer indication on results of the randomized phase 3 TOPAZ-1 trial.The international,Read More

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