Durvalumab is filed (BLA) at FDA to treat metastatic urothelial carcinoma .- AstraZeneca
AstraZeneca and its global biologics research and development arm, MedImmune, announced that the FDA has accepted the first Biologics License Application (BLA) for durvalumab, a PD-L1 human monoclonal antibody (mAb), and granted priority review status with a Prescription Drug User Fee Act (PDUFA) set for the second quarter of 2017.
The BLA submission, for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) whose disease has progressed during or after one standard platinum?based regimen, is based on the results of the UC cohort of Study 1108 and follows the FDA�s February 2016 Breakthrough Therapy Designation for durvalumab.
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