9 December 2016
AstraZeneca and its global biologics research and development arm, MedImmune, have announced that the US Food and Drug Administration (FDA) has accepted the first Biologics License Application (BLA) for durvalumab, a PD-L1 human monoclonal antibody (mAb). FDA has also 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 2016 Breakthrough Therapy Designation of FDA for durvalumab.
“The BLA acceptance of durvalumab in urothelial cancer is an important milestone for patients who still face considerable unmet medical need in this area. It also represents an exciting advance for our Immuno-Oncology medicines as we continue to develop chemotherapy-free treatments based on the potential clinical benefits of durvalumab, both as monotherapy and in combination,” said Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca.