Posted by Michael Wonder on 09 Dec 2016
US FDA accepts first biologics license application for AstraZeneca’s durvalumab in bladder cancer
9 December 2016 - FDA grants priority review status with PDUFA set for Q2 2017.
AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US FDA has accepted the first biologics license application for durvalumab, a PD-L1 human monoclonal antibody, and granted priority review status with a Prescription Drug User Fee Act set for the second quarter of 2017.
The BLA submission, for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed during or after one standard platinum‑based regimen, is based on the results of the urothelial carcinoma cohort of Study 1108 and follows the FDA’s February 2016 breakthrough therapy designation for durvalumab.
