FDA grants durvalumab priority review status with PDUFA set for 2nd-qtr 2017

The US Food and Drug Administration 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.

The positive news sent the shares of the drug’s developer, Anglo-Swedish pharma major AstraZeneca (LSE: AZN) up 4% to £42.80 by close of trading on Friday. Just in October, the FDA out a partial clinical hold on studies in patients with head and neck squamous cell carcinoma (HNSCC) with durvalumab, one of the company’s most important pipeline drugs, but this were lifted in November.