Daiichi Sankyo and AstraZeneca’s ENHERTU® Approved in EU for HER2 Low Breast Cancer
Saturday, April 05, 2025
Daiichi Sankyo and AstraZeneca have announced that the European Commission (EC) has approved ENHERTU® (trastuzumab deruxtecan) for treating adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting.
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide. More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally.
Endocrine therapy is widely given consecutively in the early lines of treatment for HR positive metastatic breast cancer. However, after initial therapy, further efficacy with additional endocrine treatment is often limited.
ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform.
This decision follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP).
The approval is based on data from the DESTINY-Breast04 Phase 3 trial, which demonstrated a significant improvement in progression-free survival and overall survival compared to standard chemotherapy.
This milestone expands ENHERTU's use to an earlier treatment setting and offers new hope for a broader group of patients with limited treatment options beyond endocrine therapy.
Source: daiichisankyo.com
