ENHERTU approved in Japan as first HER2 directed medicine for patients with HER2 low or HER2 ultralow metastatic breast cancer following at least one endocrine therapy

CAR-T Digest - August 2020

Weekly Digest - August 2025

25 August 2025: ENHERTU approved in Japan as first HER2 directed medicine for patients with HER2 low or HER2 ultralow metastatic breast cancer following at least one endocrine therapy

ENHERTU (Trastuzumab deruxtecan) has been approved in Japan as the first HER2-directed therapy for adult patients with HR-positive, HER2 low or ultralow unresectable or recurrent metastatic breast cancer following at least one endocrine therapy
The approval is based on the DESTINY-Breast06 Phase 3 trial, where ENHERTU reduced the risk of progression or death by 38% vs chemotherapy and achieved a median PFS of 13.2 months compared to 8.1 months with chemotherapy
Importantly, the benefit extended to HER2 ultralow patients, where ENHERTU also showed longer PFS (13.2 vs 8.3 months) expanding its reach to a broader patient population
This marks the fifth approved indication for ENHERTU in Japan within five years, reinforcing its role as a transformative therapy in breast cancer treatment
The safety profile was consistent with previous studies, though interstitial lung disease (ILD) remains a significant risk, requiring close monitoring and collaboration with respiratory experts during treatment