The US Food and Drug Administration granted full approval for Tagrisso once-daily tablets, for the treatment of patients with a type of advanced non-small cell lung cancer.Sean Bohen, executive vice president, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “By following the science, we aim to turn lung cancer into a chronic, manageable disease for patients and this milestone brings us one step closer to that ambition.”
The full approval in the US is based on data from the randomized, Phase III AURA3 trial, in which Tagrisso significantly improved progression-free survival (PFS) versus platinum-based doublet chemotherapy, providing 10.1 months of median PFS compared to 4.4 months from chemotherapy.
Tagrisso was granted Fast Track, Breakthrough Therapy and Priority Review designations by the US FDA, and received Accelerated Approval for this indication in 2015 based on tumor response rate and duration of response.
