ENHERTU plus Pertuzumab granted breakthrough therapy designation in the U.S. as first-line therapy for patients with HER2 positive metastatic breast cancer

CAR-T Digest - August 2020

Weekly Digest - July 2025

17 July 2025: ENHERTU plus Pertuzumab granted breakthrough therapy designation in the U.S. as first-line therapy for patients with HER2 positive metastatic breast cancer

ENHERTU (Trastuzumab deruxtecan) plus Pertuzumab has received U.S. FDA breakthrough therapy designation for first-line treatment of unresectable or metastatic HER2-positive breast cancer based on positive results from the DESTINY-Breast09 Phase 3 trial
The DESTINY-Breast09 trial showed a median PFS of over three years, marking a potential improvement over the current standard of care
This is the ninth BTD for ENHERTU and the fifth related to metastatic breast cancer, highlighting its clinical benefit across various HER2-expressing cancers
With this designation, Daiichi Sankyo now has a total of thirteen BTDs across its oncology portfolio, further supporting the strategic development of ENHERTU in partnership with AstraZeneca