The European Commission has granted marketing authorisation for Tagrisso (osimertinib) as monotherapy for the 1st-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 approval is based on results from the Phase III FLAURA trial published in the New England Journal of Medicine.
“Today’s approval is an exciting advance in bringing a potential new standard of care to patients with EGFR-mutated NSCLC in the EU. This milestone is also a step forward for our company, marking another regional approval for Tagrissoin the 1st-line setting,” said Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit at AstraZeneca.
The approval follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.