AstraZeneca and MedImmune, its global biologics research and development arm, announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for durvalumab (MEDI4736), an investigational human monoclonal antibody for the treatment of patients with a form of advanced bladder cancer.
Robert Iannone, senior vice president, head of immuno-oncology, Global Medicines Development at AstraZeneca said: “Metastatic bladder cancer is an area of enormous unmet medical need. We are encouraged by this Breakthrough Therapy designation. We look forward to working closely with the FDA to bring durvalumab to bladder cancer patients as soon as possible.”
The Breakthrough Therapy designation is designed to expedite the development of new drugs which are intended to treat a serious condition and which have shown encouraging early clinical results.
This represents the third Breakthrough Therapy designation AstraZeneca has received from the FDA for medicines in Oncology. This designation offers the opportunity for further collaboration with the FDA for the durvalumab development program. Data from study 1108 have been submitted for presentation at a future medical meeting.
AstraZeneca employs about 2.000 in Delaware.
