FDA Grants Priority Review to Durvalumab in Bladder Cancer

9 Dicembre 2016 – The FDA has granted a priority review to a biologics license application (BLA) for durvalumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed on standard platinum‑based chemotherapy, according to AstraZeneca, the manufacturer of the PD-L1 inhibitor. The BLA is based on data from the phase I/II Study 1108, in which durvalumab induced a response rate of 46% in patients with … (leggi tutto)