Posted by Michael Wonder on 12 Jul 2016
Tagrisso (osimertinib mesylate) approved by Health Canada as treatment for patients with locally advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer
1 July 2016 - A result of one of the fastest development programs from start of clinical trials to regulatory approval.
AstraZeneca Canada announced today that Health Canada has approved Tagrisso (osimertinib mesylate) once-daily tablets for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer, who have progressed on or after EGFR tyrosine kinase inhibitor therapy.
As a first-in-class treatment, Tagrisso has been granted the Health Canada Notice of Compliance with Conditions, based on promising evidence of clinical efficacy data, pending the results of additional trials to verify its clinical benefit.
