AZ's Imfinzi gets Priority Review for NSCLC that has not progressed

AstraZeneca plc (LSE:AZN; NYSE:AZN) said FDA accepted and granted Priority Review to an sBLA for PD-L1 mAb Imfinzi durvalumab to treat locally advanced unresectable non-small cell lung cancer (NSCLC) that has not progressed following platinum-based chemoradiation therapy. AZ expects a decision from FDA in 1H18.

The sBLA is based on data from the Phase III PACIFIC trial, in which Imfinzi met the co-primary endpoint of improving progression-free survival (PFS) (see BioCentury, May 18)...