Posted by Michael Wonder on 30 Apr 2018
Tagrisso receives positive EU CHMP opinion for first-line treatment of EGFR-mutated non-small cell lung cancer
27 April 2018 - Recommendation based on FLAURA trial data showing unprecedented median progression-free survival of 18.9 months for Tagrisso versus 10.2 months compared with current standard of care.
The CHMP of the European Medicines Agency has adopted a positive opinion, recommending a change to the terms of the Marketing Authorisation for Tagrisso (osimertinib) to include the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.
The recommendation is based on results from the Phase III FLAURA trial, which were presented at the European Society of Medical Oncology 2017 Congress and published in the New England Journal of Medicine.
