17 July 2025 - Ninth breakthrough therapy designation for Daiichi Sankyo and AstraZeneca’s Enhertu with the latest based on DESTINY-Breast09 Phase 3 trial results.
Enhertu (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab has been granted breakthrough therapy designation in the US for the first-line treatment of adult patients with unresectable or metastatic HER2 positive breast cancer.