Pharmaceutical giant AstraZeneca (AZN) said on Tuesday that lung cancer drug Tagrisso had been granted Priority Review in the US with an expected decision date during the first-quarter of 2021. The shares added 0.4% to £81.40.
The US Food and Drug Agency (FDA) grants priority review to applications that offer significant improvements over available options by demonstrating safety or efficacy improvements.
The ‘unprecedented results’ achieved by the ADAURA Phase three trials announced in May demonstrated a ‘statistically and clinically meaningful improvement in disease-free survival’ for patients with early-stage lung cancer.
As reported on 29 May, efficacy was so strong that an independent data monitoring committee recommended the trial be unblinded two years early.
A double-blind study involves giving half the patients a placebo and comparing results with the half taking the test drug, ensuring the results have statistical validity. Neither the patients nor the experimenters know who is receiving the drug.
Executive vice president of the Oncology business unit, Dave Fredrickson, commented, ‘this expedited review underscores the unprecedented disease-free survival benefit Tagrisso brings to patients in the adjuvant setting, and we will continue working with the FDA to provide this practice-changing treatment to patients as quickly as possible’.
In addition AstraZeneca has received acceptance for a supplemental new drug application for Tagrisso after its Breakthrough Therapy Designation in July 2020, which was based upon ‘overwhelming efficacy’ from the ADAURA trial.