AstraZeneca and its global biologics research and development arm, MedImmune, 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), 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.
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “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.”
As part of a broad development programme, durvalumab is being tested as monotherapy and in combination with tremelimumab (CTLA-4 mAb) in the Phase III DANUBE trial as 1st-line treatment for patients with metastatic UC, regardless of eligibility for cisplatin-based chemotherapy.
The combination of durvalumab and tremelimumab is also being studied in Phase III trials in non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC) and in Phase II and earlier trials in gastric cancer, pancreatic cancer, hepatocellular carcinoma (HCC) and blood cancers. AstraZeneca currently has more than 30 ongoing durvalumab clinical trials in combination with other IO agents and targeted therapies.