ENHERTU Type II Variation Application validated in the EU as post-neoadjuvant treatment for patients with HER2 positive early breast cancer

CAR-T Digest - August 2020

Weekly Digest - February 2026

19 February 2026: ENHERTU Type II Variation Application validated in the EU as post-neoadjuvant treatment for patients with HER2 positive early breast cancer

The European Medicines Agency has validated a Type II Variation application for ENHERTU (trastuzumab deruxtecan) as monotherapy for adult patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant HER2-targeted treatment, initiating the formal scientific review by the Committee for Medicinal Products for Human Use
The submission is supported by results from the Phase 3 DESTINY-Breast05 trial, presented at ESMO 2025 and later published in The New England Journal of Medicine, demonstrating that ENHERTU significantly improved invasive disease-free survival compared with trastuzumab emtansine (T-DM1)
In the study, ENHERTU reduced the risk of invasive disease recurrence or death by 53% versus T-DM1 in patients with HER2-positive breast cancer who had residual disease following neoadjuvant therapy, a population known to be at high risk of relapse
If approved, ENHERTU has the potential to become a new standard of care in the post-neoadjuvant setting, offering a more effective option to reduce recurrence and progression to metastatic disease in early-stage HER2-positive breast cancer
This validation adds to a series of ongoing regulatory efforts in the EU for ENHERTU across multiple breast and solid tumor indications, further expanding its role across earlier and advanced stages of HER2-positive disease