The U.S. FDA has granted Breakthrough Therapy designation for durvalumab

AstraZeneca and its research and development subsidiary, MedImmune, announced this week that the U.S. Food and Drug Administration (FDA) has granted durvalumab (MEDI4736) Breakthrough Therapy designation (BTD).

Durvalumab is an investigational human monoclonal antibody developed to combat programmed death ligand (PD-L1). The drug is designed for patients with PD-L1 positive metastatic urothelial bladder cancer that is inoperable or in cases where the tumor has advanced during or after one platinum-based therapy. Metastatic bladder cancer is considered an area where there is a lack of viable treatment options.

The BTD is the first step to seeing new drugs developed for serious diseases and conditions in areas of the medical field that have the most unmet needs. Any drug that is awarded a BTD has shown promise in its clinical trials. Durvalumab was granted a BTD because of the data record during its Phase I trial (Study 1108).

The BTD designation is AstraZeneca’s third for its prototype medications in oncology. This opens the door to work with the FDA to further develop durvalumab. The data from Study 1108 has been submitted to the FDA and will be presented at a later date.