FDA granted Priority Review for Imfinzi (durvalumab) in combination with standard-of-care chemotherapy, for patients with locally advanced or metastatic biliary tract cancer (BTC).
The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending approval of Keytruda (pembrolizumab) in combination with gemcitabine and cisplatin, for the first-line treatment of adult patients with locally advanced unresectable or metastatic biliary tract carcinoma.
