AstraZeneca and MedImmune, its global biologics research and development arm, on Wednesday announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) 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 tumour has progressed during or after one standard platinum-based regimen.
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, which demonstrate substantial improvement on a clinically significant endpoint over available therapies or when there is significant unmet medical need.
The Breakthrough Therapy designation for durvalumab was granted by the FDA on the basis of early clinical data from a Phase I trial (Study 1108) in patients with advanced metastatic urothelial bladder cancer whose tumour has progressed during or after one standard platinum-based regimen. 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 programme. Data from study 1108 have been submitted for presentation at a future medical meeting.
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.