AstraZeneca says European Commission green-lights marketing for its Tagrisso to treat lung cancer

Anglo-Swedish drug major AstraZeneca (LSE: ANZ) on Wednesday said the European Commission (EC) has granted conditional marketing authorization for Tagrisso (osimertinib) to treat non-small cell lung cancer (NSCLC).

Sean Bohen, chief medical officer at AstraZeneca, said: “Osimertinib defines a new generation of targeted EGFR-TKI treatments, and the European Commission’s expedited approval reflects the importance of this innovative medicine for addressing the needs of patients with lung cancer who have the T790M mutation. We are now building on our understanding of the clinical activity of osimertinib to explore its full potential in patients with EGFRm lung cancer in multiple treatment settings.”

The company said the EU approval for osimertinib is based on data from two Phase II studies, which demonstrated efficacy in 474 patients. In the combined Phase II studies, the objective response rate was 66%, and in the Phase I study it was 62%. Progression-free survival (PFS) was 9.7 months in the combined Phase II studies and 11 months in the Phase I trial.