Priority Review for durvalumab in bladder cancer

AstraZeneca plc (NYSE:AZN; LSE:AZN) said FDA accepted and granted Priority Review to a BLA for durvalumab (MEDI4736) to treat locally advanced or metastatic urothelial carcinoma in patients who have progressed after one standard platinum-based regimen. Its PDUFA date is in 2Q17.

The human IgG1 mAb targeting PD-L1 has breakthrough therapy designation to treat PD-L1-positive inoperable or metastatic urothelial carcinoma...