Posted by Michael Wonder on 04 Feb 2018
Tagrisso (osimertinib) receives full Health Canada approval for targeted treatment of non-small-cell lung cancer
31 January 2018 - Approval based on Phase III AURA3 trial that demonstrated significant improvement in progression-free survival with Tagrisso compared to chemotherapy.
AstraZeneca Canada announces that Health Canada has granted full approval (Notice of Compliance) for Tagrisso (osimertinib) for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC) whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.
This full approval follows a Notice of Compliance with Conditions for Tagrisso that was granted in July, 2016. The full approval was based on results from the randomised Phase III AURA3 trial demonstrating that Tagrisso is superior to chemotherapy in prolonging progression-free survival. Tagrisso is the first and only approved medicine indicated for NSCLC patients who have tested positive for the EGFR T790M mutation.
