The FDA granted priority review to durvalumab for the treatment of patients with locally advanced unresectable non-small cell lung cancer whose disease has not progressed following platinum-based chemoradiation therapy.
The supplemental biologics license application included positive PFS data from the randomized, double-blind, placebo-controlled multicenter phase 3 PACIFIC trial of durvalumab (Imfinzi; AstraZeneca, MedImmune), a human monoclonal antibody directed against PD-L1.
PFS and OS served as the primary endpoints. Secondary endpoints included landmark PFS and OS, objective response rate and duration of response.
