Biopharmaceutical company AstraZeneca (STO:AZN) (LON:AZN) reported on Tuesday that the US Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for Tagrisso (osimertinib) and has granted Priority Review for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent.

The Prescription Drug User Fee Act date, the action date for the FDA's regulatory decision, is in the first quarter of 2021.

The sNDA was based on results from the ADAURA Phase III trial in which Tagrisso demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) in the primary analysis population of patients with Stage II and IIIA EGFRm NSCLC, and also in the overall trial population of patients with Stage IB-IIIA disease, a key secondary endpoint.

Tagrisso received Breakthrough Therapy Designation in this setting in July 2020. It is already approved for both the first-line treatment of patients with locally advanced or metastatic EGFRm NSCLC and for the treatment of locally advanced or metastatic EGFR T790M mutation-positive NSCLC in the US, Japan, China, the EU and other countries around the world.