Enhertu plus pertuzumab approved in the US as first new treatment in a decade for the 1st-line treatment of patients with HER2-positive metastatic breast cancer

CAR-T Digest - August 2020

Weekly Digest - December 2025

15 December 2025: Enhertu plus pertuzumab approved in the US as first new treatment in a decade for the 1st-line treatment of patients with HER2-positive metastatic breast cancer

The US FDA has approved AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) in combination with pertuzumab as a 1st-line treatment for adults with unresectable or metastatic HER2-positive breast cancer, marking the first major advance in this setting in more than a decade
This approval is supported by results from the Phase 3 DESTINY-Breast09 trial, with data presented at the 2025 ASCO Annual Meeting and published in The New England Journal of Medicine, following Priority Review, Breakthrough Therapy Designation, and Real-Time Oncology Review by the FDA
In DESTINY-Breast09, Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus the current standard THP regimen, delivering a median progression-free survival of 40.7 months compared with 26.9 months, with benefits consistently observed across patient subgroups
Investigators and company leaders highlighted that achieving more than three years without disease progression in the 1st-line metastatic setting sets a new benchmark, positioning Enhertu plus pertuzumab as a potential new standard of care for patients with HER2-positive disease
Beyond its clinical impact, the approval carries global and strategic significance, with regulatory reviews underway in Switzerland and Singapore under Project Orbis and a $150 million milestone payment due from AstraZeneca to Daiichi Sankyo, reinforcing Enhertu’s growing role as a practice-changing HER2-directed ADC