AstraZeneca said on Friday that European regulators have adopted a positive opinion of its Tagrisso drug and recommended a change to the terms of the marketing authorisation to include the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with activating epidermal growth factor receptor (EGFR) mutations.
The recommendation from the Committee for Medicinal Products for Human Use of the European Medicines Agency is based on results from the Phase 3 Flaura trial, which were presented at the European Society of Medical Oncology 2017 Congress and published in the New England Journal of Medicine.

Sean Bohen, executive vice president of Global Medicines Development and chief medical officer, said: "This positive recommendation acknowledges Tagrisso's potential as a new first-line standard of care for patients with EGFR-mutated NSCLC in Europe.

"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."

At 1530 BST, the shares were up 1.3% to 5,059p.

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