AstraZeneca’s Tagrisso receives full EU approval based on Phase III AURA3 data

The European Commission (EC) has granted full marketing authorisation for AstraZeneca’s Tagrisso (osimertinib) 40mg and 80mg once-daily tablets for the treatment of adult patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).
The full EC approval for Tagrisso is based on the results of the Phase III AURA3 trial, which were presented last year. The EGFR T790M mutation can be detected with a validated test using either DNA derived from a biopsy or circulating tumour DNA obtained from a plasma sample.
Data from the Phase III AURA3 trial showed that Tagrisso demonstrated statistically-significant improvements in progression-free survival (PFS) over standard platinum-based doublet chemotherapy in 419 patients with EGFR T790M-positive advanced NSCLC whose disease had progressed on or after EGFR TKI therapy. Among patients taking Tagrisso, the PFS was 10.1 months, compared to 4.4 months in the chemotherapy arm. The objective response rate was 71% compared to 31% for chemotherapy. Among 144 patients with metastases to the central nervous system, PFS was 8.5 months versus 4.2 months.
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “Tagrisso has the potential to become the new standard of care for patients with this difficult-to-treat form of lung cancer.”