Posted by Michael Wonder on 01 Mar 2025
Enhertu recommended for approval in the EU by CHMP for patients with HER2 low or HER2 ultra-low metastatic breast cancer following at least one endocrine therapy
28 February 2025 - Recommendation based on DESTINY-Breast06 Phase 3 trial results which showed Enhertu demonstrated superiority versus chemotherapy with a median progression-free survival of more than one year.
Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultra-low (IHC 0 with membrane staining) breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment.
