AstraZeneca PLC said the European Medicines Agency accepted its submission for Tagrisso as a first-line treatment for a certain type of lung cancer.
The company submitted a variation to its marketing authorization application to use Tagrisso, or osimertinib, to treat adults with locally advanced or metastatic non-small cell lung cancer, or NSCLC, whose tumors have epidermal growth factor receptor, or EGFR, mutations.
The submission is based on data from the phase 3 Flaura trial, under which Tagrisso significantly improved progression-free survival compared to erlotinib or gefitinib in previously-untreated patients with locally-advanced or metastatic EGFRm NSCLC.
Recently, AstraZeneca sought Japan's approval to use Tagrisso as first-line treatment of patients in inoperable or recurrent EGFR-mutated NSCLC.
