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AstraZeneca (AZN) Reports FDA Acceptance of Supplemental Biologics License Application for IMFINZI (Durvalumab)
October 17, 2017 7:04 AM EDTAstraZeneca (NYSE: AZN) 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, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy. The FDA has granted IMFINZI Priority Review status.
The US FDA sBLA submission acceptance is an important milestone for IMFINZI in a disease state where patients need better treatment options and outcomes. Currently, the standard of... More
