Uro Pipeline: FDA accepts biologics license application for
AstraZeneca, along with its research and development branch, MedImmune, has received a biologics license application (BLA) from the FDA for the investigational agent durvalumab. The BLA submission is for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed during or after a platinum-based regimen. Durvalumab, a PD-L1 human monoclonal antibody (mAb), was also was granted priority review status with a Prescription Drug User Fee Act date set for the second quarter of 2017. In the phase III DANUBE trial, durvalumab is being tested both as a monotherapy and in combination with tremelimumab (CTLA-4 mAB).