Cambridge, UK–based AstraZeneca (Nasdaq:AZN) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended a new marketing authorization of Imfinzi (durvalumab).
The recommendation specifically refers to the first-line treatment of adults with unresectable or metastatic biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine with cisplatin).
In an interim analysis, durvalumab with chemotherapy was associated with a 20% reduction in the risk of death compared to chemotherapy as a monotherapy.
The TOPAZ-1 study found a 24% reduction in the risk of death compared to chemotherapy alone after an additional 6.5 months. In addition, the company estimates that twice as many patients of durvalumab and chemotherapy were alive at two years compared to those on chemotherapy alone.
AstraZeneca notes that durvalumab was generally well tolerated in the TOPAZ-1 study. A total of 60.9…