BRIEF—AstraZeneca looks to extend Tagrisso label in Europe

AstraZeneca has announced that the European Medicines Agency has accepted and will review its application to broaden the label for Tagrisso (osimertinib).

The firm is seeking approval to market its tyrosine kinase inhibitor (TKI) for the first-line treatment of certain non-small cell lung cancer (NSCLC) patients.

Yesterday the firm announced that it had applied to extend the Japanese label for the drug to cover the same indication.

The application is based on data from the Phase III FLAURA trial, which showed improved progression-free survival compared to Tarceva (erlotinib), which is co-developed by Roche and Astellas, and the firm’s own Iressa (gefitinib).