Posted by Michael Wonder on 31 Mar 2017
Tagrisso (osimertinib) receives US FDA full approval
31 March 2017 - Approval based on Phase III AURA3 trial that demonstrated significant improvement in progression-free survival with Tagrisso as compared to chemotherapy.
AstraZeneca today announced that the US FDA has granted full approval for Tagrisso (osimertinib) 80mg once daily tablets, for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after an EGFR tyrosine kinase inhibitor (TKI) therapy.
Tagrisso is the first and only approved medicine in the US indicated for NSCLC patients who have tested positive for the EGFR T790M mutation, and efficacy data suggest it may be a new standard of care for these patients.
