Posted by Michael Wonder on 19 Feb 2026
Enhertu type II variation application validated in the EU as post-neoadjuvant treatment for patients with HER2 positive early breast cancer
19 February 2026 - Based on DESTINY-Breast05 Phase 3 trial results, which showed Enhertu reduced the risk of invasive disease recurrence or death by 53% compared to trastuzumab emtansine.
The EMA has validated the type II variation marketing authorisation application for Enhertu (trastuzumab deruxtecan) as a monotherapy for adult patients with HER2 positive (immunohistochemistry 3+ or in situ hybridisation +) breast cancer who have residual invasive disease after neo-adjuvant HER2 targeted treatment.
