Durvalumab is being developed for the treatment of PD-L1—positive patients with inoperable or metastatic urothelial bladder cancer
The FDA has granted breakthrough designation to AstraZeneca’s programmed death-ligand 1 (PD-L1) inhibitor durvalumab, according to Reuters. Breakthrough designation places drugs with encouraging clinical results that treat life-threatening conditions on a fast track for approval.
A company press release said that the investigational monoclonal antibody is being developed for the treatment of PD-L1—positive patients with inoperable or metastatic urothelial bladder cancer who have progressed on a standard platinum-based treatment regimen. Early data from a phase 1 trial in patients with advanced metastatic urothelial bladder cancer were submitted for FDA review and resulted in the breakthrough status.
Robert Iannone, senior vice president and 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 company is also evaluating durvalumab as first-line in bladder cancer as a monotherapy as well as in combination with tremelimumab as part of the DANUBE phase 3 trial.