BioCentury
ARTICLE | Clinical News

FDA approves AZ's Imfinzi for NSCLC that has not progressed

February 23, 2018 8:20 PM UTC

FDA approved Imfinzi durvalumab from AstraZeneca plc (LSE:AZN; NYSE:AZN) to treat stage III unresectable non-small cell lung cancer that has not progressed following chemoradiation. The agency said this is the first drug approved for the indication.

FDA said AstraZeneca agreed to a postmarketing commitment to provide the agency with overall survival (OS) data from the Phase III PACIFIC trial in the indication. In the study, Imfinzi led to a median progression-free survival (PFS) of 16.8 vs. 5.6 months for placebo (HR=0.52, 95% CI: 0.42, 0.65, p<0.001) in the "all-comer" population. The trial enrolled 713 patients with locally advanced, unresectable NSCLC who did not progress following platinum-based chemotherapy concurrent with radiation (see BioCentury, Sept. 14, 2017)...