Enhertu approved in Canada as the first and only HER2-directed therapy for patients with HR-positive HER2-low or HER2-ultralow metastatic breast cancer, following disease progression after one or more endocrine therapies

CAR-T Digest - August 2020

Weekly Digest - October 2025

29 October 2025: Enhertu approved in Canada as the first and only HER2-directed therapy for patients with HR-positive HER2-low or HER2-ultralow metastatic breast cancer, following disease progression after one or more endocrine therapies

Health Canada has approved Enhertu (Trastuzumab deruxtecan) as the first and only HER2-directed therapy for adults with HR-positive, HER2-low or HER2-ultralow metastatic breast cancer, post-endocrine therapy progression
Approval follows strong results from the Phase 3 DESTINY-Breast06 trial, which showed a 36% reduction in disease progression or death versus chemotherapy
Patients receiving ENHERTU achieved median PFS of 13.2 months compared to 8.1 months with chemotherapy, and a confirmed ORR of 57.3% versus 31.2% respectively
Findings, published in The New England Journal of Medicine, reinforce Enhertu’s superiority in HER2-low and ultralow breast cancer settings
The combination therapy is already approved in several international markets (EU, UK, Japan, Canada, Switzerland, Brazil), with applications under review globally, including in China under breakthrough therapy and priority review designations