AstraZeneca PLC and MedImmune's Imfinzi was granted priority review status by the U.S. Food and Drug Administration as it accepted a supplemental biologics license application, or sBLA, for the lung cancer treatment.
The sBLA is based on positive data from the phase 3 Pacific trial of Imfinzi. The study is continuing to evaluate overall survival under the treatment, the trial's other primary endpoint.
Imfinzi or durvalumab, is a monoclonal antibody indicated for treating patients with locally advanced, or Stage 3, unresectable non-small cell lung cancer whose disease has not progressed following platinum-based chemoradiation therapy.
Imfinzi was granted breakthrough therapy designation by the U.S. FDA in July.
MedImmune is AstraZeneca's biologics research and development unit.