AstraZeneca PLC's Tagrisso was granted breakthrough therapy designation by the U.S. Food and Drug Administration for first-line treatment of patients with a certain type of lung cancer.

The FDA granted the designation based on data from the phase 3 FLAURA trial of Tagrisso versus standard-of-care therapy in previously-untreated patients.

Tagrisso, or osimertinib, is currently approved in over 50 countries, including the U.S. and EU, as a second-line of treatment for patients with locally advanced or epidermal growth factor receptor-mutated nonsmall cell lung cancer.