Drugmakers AstraZeneca in Wilmington and its biotechnology subsidiary MedImmune said Wednesday the Food and Drug Administration has granted "breakthrough therapy designation" for their human monoclonal antibody, Durvalumab, to treat patients with inoperable or metastic urothelial bladder cancer.
The FDA designation is meant to expedite development of new drugs to treat a serious condition when early clinical trials showed encouraging results. Urothelial bladder cancer is the ninth most common cancer worldwide. In 2013, there were 400,000 cases of bladder cancer and 173,000 deaths worldwide. Metastatic bladder cancer is "an area great unmet medical need with five-year survival rates of less than 15 percent," the companies said.
Oncology has been a focus area for AstraZeneca, which said it expects at least six new medicines to be launched between 2014 and 2020.
AstraZeneca employs 2,100 in Delaware at its North American headquarters in Wilmington and a manufacturing plant in Newark. MedImmune, based in Gaithersburg, Md. is AstraZeneca's biologics and research and development arm. AstraZeneca's global headquarters is in London.