Posted by Michael Wonder on 23 Jul 2019
Imfinzi (durvalumab) US label updated with overall survival data in unresectable, Stage III non-small cell lung cancer
22 July 2019 - Imfinzi is the only immunotherapy approved to treat patients in this curative-intent setting following chemoradiation therapy.
AstraZeneca today announced that the US FDA has approved the inclusion of overall survival (OS) data from the Phase III PACIFIC trial in an update to the Imfinzi (durvalumab) US Prescribing Information for patients with unresectable, Stage III non-small cell lung cancer whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
The label update was based on results from the primary OS analysis published in The New England Journal of Medicine in September 2018 which demonstrated a significant and clinically-proven OS benefit for treatment with Imfinzi vs placebo in this setting, reducing the risk of death by 32% (HR 0.68, 95% CI, 0.53-0.87; P=0.0025).
