The Investor
19 Feb 2026, 10:13
ENHERTU has advanced in its regulatory pathway in Europe, with the European Medicines Agency validating a Type II Variation application for its use as post-neoadjuvant treatment in patients with HER2-positive early breast cancer.
The application seeks approval for ENHERTU as a monotherapy in adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant HER2-targeted therapy. Validation by the EMA confirms that the submission is complete and initiates the scientific review process by the Committee for Medicinal Products for Human Use (CHMP).
The filing is supported by results from the Phase 3 DESTINY-Breast05 trial, where ENHERTU demonstrated a 53% reduction in the risk of invasive disease recurrence or death compared with trastuzumab emtansine (T-DM1). The data were presented at the 2025 European Society for Medical Oncology Congress and published in The New England Journal of Medicine.
Developed by Daiichi Sankyo and co-developed and commercialized with AstraZeneca, ENHERTU is a HER2-directed DXd antibody-drug conjugate. If approved, it could become a new standard of care for patients with residual invasive HER2-positive early breast cancer following neoadjuvant therapy.
Additional EU regulatory submissions for ENHERTU are also underway, including combination use with pertuzumab in first-line metastatic HER2-positive breast cancer and expanded indications across other HER2-positive solid tumors.
The application seeks approval for ENHERTU as a monotherapy in adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant HER2-targeted therapy. Validation by the EMA confirms that the submission is complete and initiates the scientific review process by the Committee for Medicinal Products for Human Use (CHMP).
The filing is supported by results from the Phase 3 DESTINY-Breast05 trial, where ENHERTU demonstrated a 53% reduction in the risk of invasive disease recurrence or death compared with trastuzumab emtansine (T-DM1). The data were presented at the 2025 European Society for Medical Oncology Congress and published in The New England Journal of Medicine.
Developed by Daiichi Sankyo and co-developed and commercialized with AstraZeneca, ENHERTU is a HER2-directed DXd antibody-drug conjugate. If approved, it could become a new standard of care for patients with residual invasive HER2-positive early breast cancer following neoadjuvant therapy.
Additional EU regulatory submissions for ENHERTU are also underway, including combination use with pertuzumab in first-line metastatic HER2-positive breast cancer and expanded indications across other HER2-positive solid tumors.