FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

European Commission Clears AstraZeneca’s Tagrisso for Marketing

May 1, 2017
A A

The European Commission granted marketing authorization for AstraZeneca’s Tagrisso tablets for the treatment of adult patients with locally-advanced or metastatic epidermal growth factor receptor T790M mutation-positive non-small cell lung cancer.

Clinical results showed that Tagrisso demonstrated statistically-significant improvements in progression-free survival over standard platinum-based doublet chemotherapy in patients whose disease had progressed on or after EGFR TKI therapy.

The FDA granted Tagrisso approval in March. The product was also recently approved in China through the priority review pathway.

View today's stories