FDA accepts sBLA file for Imfinzi; priority review
17 October 2017 07:00 BST US FDA ACCEPTS SUPPLEMENTAL BIOLOGICS LICENSE APPLICATION FOR IMFINZI IN LOCALLY ADVANCED UNRESECTABLE NON-SMALL CELL LUNG CANCER Imfinzi granted Priority Review Acceptance follows FDA's Breakthrough Therapy Designation AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) for the treatment of patients with locally advanced (Stage III) unresectable non-small cell lung cancer (