Tagrisso wins EU approval for 1st-line treatment of EGFR-mutated NSCLC

11 June 2018

On Friday, the European Commission granted marketing authorization for Tagrisso (osimertinib) as monotherapy for 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 approval, says the drug’s developer AstraZeneca (LSE: AZN), is based on results from the Phase III FLAURA trial published in the New England Journal of Medicine.

This latest approval is welcome news for AstraZeneca, which is struggling to maintain sales following several of its leading drugs losing patent exclusivity and facing generic competition, and will help the company to achieve the $3 billion-plus sales target it has placed on Tagrisso. However, it still has to compete with Merck & Co’s formidable Keytruda-chemo combo in the marketplace.

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