A positive opinion has been adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, recommending a change to the terms of the marketing authorisation for AstraZeneca’s Tagrisso (osimertinib) to include first-line treatment.
Lungs
The recommendation to include first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EFGR) mutations has been based on the results of the Phase III FLAURA trial.
“This positive recommendation acknowledges Tagrisso’s potential as a new 1st-line standard of care for patients with EGFR-mutated NSCLC in Europe,” stated Sean Bohen, executive vice president, Global Medicines Development and chief medical officer at AstraZeneca. “It reflects the strength of the FLAURA data that show Tagrisso delivered a statistically-significant and clinically-meaningful improvement in progression-free survival over the EGFR-TKI comparator arm across all pre-specified patient subgroups, including those with or without central nervous system metastases.”
The results from the FLAURA trial were presented at the European Society of Medical Oncology 2017 Congress and published in the New England Journal of Medicine.
This CHMP positive opinion will now be reviewed by the European Commission, which has the authority to approve medicines for the 28 EU member countries plus Iceland, Norway and Liechtenstein.