18 May 2020 - Designation based on phase 2 DESTINY-Lung01.
Daiichi Sankyo and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) has been granted breakthrough therapy designation in the U.S. for the treatment of patients with metastatic non-small cell lung cancer whose tumours have a HER2 mutation and with disease progression on or after platinum-based therapy.
This is the third breakthrough therapy designation for Enhertu, highlighting its potential to treat multiple HER2 cancers.