FDA Grants Durvalumab Breakthrough Designation for Bladder Cancer

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to the investigational human IgG1 monoclonal antibody durvalumab (MEDI4736) for patients with inoperable or metastatic urothelial bladder cancer that is programmed-cell-death-ligand 1 (PD-L1)-positive and refractory to platinum-based treatment.

“Metastatic bladder cancer is an area of enormous unmet medical need,” said Robert Iannone, MD, Senior Vice President, Head of Immuno-Oncology, Global Medicines Development at AstraZeneca, in a press release. “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.”

Durvalumab inhibits PD-L1 binding to PD-1 and CD80, facilitating antitumor immune response. It is undergoing clinical testing as first-line monotherapy and in combination with tremelimumab against bladder cancer in the DANUBE phase III trial, which began accruing patients in late 2015.

Breakthrough Therapy Designation hastens drug development for investigational agents that demonstrate substantial clinical improvement over available therapies. The FDA granted this designation to durvalumab after reviewing early phase I clinical trial data, which will be presented at an upcoming medical conference, according to an AstraZeneca press release.

A comprehensive durvalumab registration program is currently underway across multiple tumor types (bladder, head and neck, gastric, pancreatic, liver, blood, and non-small cell lung cancer), stages of disease, and includes various treatment regimens such as durvalumab monotherapy and in combination with other anticancer agents.