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AstraZeneca: FDA Grants Priority Review For Imfinzi - Quick Facts

AstraZeneca plc (AZN.L,AZN) announced the US FDA has accepted a supplemental Biologics License Application and granted Priority Review for Imfinzi for the treatment of patients with previously untreated extensive-stage small cell lung cancer. The sBLA was based on positive results from the Phase III CASPIAN trial. The PDUFA date is set for the first quarter of 2020.

Imfinzi is approved in the curative-intent setting of unresectable, Stage III non-small cell lung cancer after chemoradiation therapy in 54 countries, including the US, Japan and the EU.

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