Posted by Michael Wonder on 25 Apr 2017
Tagrisso receives full approval in the EU
25 April 2017 - Full approval follows Tagrisso’s expedited conditional marketing authorisation as first-in-class medicine for patients with locally-advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer.
AstraZeneca today announced that the European Commission has granted full marketing authorisation for Tagrisso (osimertinib) 40 mg and 80 mg 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.
The full 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 (ctDNA) obtained from a plasma sample.
