The EC approval is based on results from the Phase 3 ADAURA trial, in which Tagrisso reduced the risk of disease recurrence or death by 80%
AstraZeneca Cambridge R&D Centre aerial view. (Credit: AstraZeneca.)
AstraZeneca has received the European Commission (EC) approval for Tagrisso (osimertinib) for the adjuvant treatment of adult patients with a type of non-small cell lung cancer (NSCLC).
Tagrisso is indicated for early-stage epidermal growth factor receptor-mutated (EGFRm) NSCLC patients whose tumours have exon 19 deletions or exon 21 mutations.
The drug is a third-generation, irreversible EGFR TKI that has shown clinical activity against central nervous system metastases.
AstraZeneca oncology business unit executive vice president Dave Fredrickson said: “We know the earlier a patient’s cancer is detected and treated, the greater chance they may have of being cured, which is why this approval is significant.
“For the first time, patients in the EU with EGFR-mutated lung cancer have a targeted, biomarker-driven treatment option available in the early stages of their disease that can help them live cancer-free longer.”
The EC approval is based on positive results from ADAURA, a randomised, double-blind, global, placebo-controlled Phase 3 trial in 682 patients with Stage IB, II and IIIA EGFRm NSCLC.
The trial enrolled patients in more than 200 centres across more than 20 countries, including the US, Europe, South America, Asia and the Middle East.
In the Phase 3 trial, treatment using once-daily Tagrisso 80mg oral tablets showed statistically significant and clinically meaningful improvement in disease-free survival (DFS) in Stage II and IIIA patients, the primary endpoint.
Also, the drug showed a statistically significant and clinically meaningful improvement in DFS in the overall trial population, a key secondary endpoint in the trial.
Tagrisso reduced 83% risk of disease recurrence or death in patients with Stage II and IIIA disease and by 80% in the overall trial population of patients with Stage IB-IIIA disease.
In the clinical trial, the safety and tolerability of the drug were consistent with previous trials in the metastatic setting.
Tagrisso is currently approved to treat early-stage lung cancer in more than 50 countries, including in the US and China, with additional global regulatory reviews underway.
Also, it was approved to treat patients with metastatic EGFRm NSCLC and EGFR T790M mutation-positive NSCLC in the EU, the US, Japan, China and many other countries.