FDAnews
www.fdanews.com/articles/175440-fda-grants-breakthrough-designation-to-azs-durvalumab

FDA Grants Breakthrough Designation to AZ’s Durvalumab

February 23, 2016

AstraZeneca has reeled in breakthrough therapy designation for its PD-L1 therapy durvalumab, for the treatment of urothelial bladder cancer.

The treatment caters to patients with PD-L1 positive inoperable or metastatic urothelial bladder cancer whose tumor has progressed during or after one standard platinum-based chemotherapy regimen. Durvalumab also is being studied for first-line bladder cancer treatment as monotherapy, as well as in combination with tremelimumab.

It also is being developed to treat hepatocellular carcinoma and lung, gastric, pancreatic and blood cancers.