AstraZeneca and MedImmune, its global biologics research and development arm, announced that the U.S. FDA has granted Breakthrough Therapy designation for durvalumab (MEDI4736), an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1), for the treatment of patients with PD-L1 positive inoperable or metastatic urothelial bladder cancer whose tumor has progressed during or after one standard platinum-based regimen.  Durvalumab is also being tested in first-line bladder cancer as a monotherapy as well as in combination with tremelimumab as part of the DANUBE Phase III trial which achieved first patient in during the final quarter of 2015.

Urothelial bladder cancers arise from the epithelium of the bladder and are the 9th most common form of cancer worldwide. Based on the Global Burden of Disease Cancer Collaboration, it is estimated that there were 400,000 incidents of bladder cancer and 173,000 deaths worldwide for the year 2013. Metastatic bladder cancer remains an area of great unmet medical need with 5-year overall survival rates of less than 15%.