Imfinzi granted FDA Priority Review for the treatment of patients with extensive-stage small cell lung cancer
AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for Imfinzi (durvalumab) for the treatment of patients with previously untreated extensive-stage small cell lung cancer (SCLC). SCLC is an aggressive, fast-growing form of lung cancer that recurs and progresses rapidly despite initial response to platinum-based chemotherapy.[1] A Prescription Drug User Fee Act date is set for the first quarter of 2020. The sBLA was based on positive results from the Phase III CASPIAN