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FDA Accepts Supplemental Biologics License Application for Durvalumab in Unresectable NSCLC

By: Sarah Jackson
Posted: Monday, October 23, 2017

The U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application for durvalumab (Imfinzi) for the treatment of patients with stage III unresectable non–small cell lung cancer whose disease has not progressed following platinum-based chemoradiation therapy, announced AstraZeneca and MedImmune on October 17, 2017.

The supplemental Biologics License Application submission is based on the results from the randomized, double-blind phase III PACIFIC trial, which was conducted across 235 cancer centers spanning 26 countries. Detailed results of the trial were published in The New England Journal of Medicine.

Of the 713 patients who underwent randomization in the PACIFIC trial, 709 received consolidation therapy (473 durvalumab and 236 placebo). The median progression-free survival was 16.8 months with durvalumab versus 5.6 months with placebo. The 12-month progression-free survival rate was 55.9% versus 35.3%, and the 18-month progression-free survival rate was 44.2% versus 27.0%.