FDA OKs including new survival data in labeling of AstraZeneca’s Imfinzi

AstraZeneca (NYSE:AZN) perks up 1% premarket on light volume following its announcement that the FDA has signed off on including overall survival (OS) data from the Phase 3 PACIFIC study in the package insert of IMFINZI (durvalumab) for patients with unresectable Stage III non-small cell lung cancer (NSCLC) who have not progressed following concurrent platinum-based chemo and radiation therapy.

The data showed an OS benefit compared to placebo with a 32% reduction in the risk of death.

https://seekingalpha.com/news/3479613-fda-oks-inclusion-new-survival-data-labeling-astrazenecas-imfinzi-shares-1-percent-premarket