Posted by Michael Wonder on 19 Aug 2024
Enhertu type II variation application validated by EMA for patients with HER2 low or HER2 ultralow metastatic breast cancer following at least one endocrine therapy
19 August 2024 - Submission based on DESTINY-Breast06 Phase 3 trial results that showed Daiichi Sankyo and AstraZeneca’s Enhertu demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to standard of care chemotherapy
Daiichi Sankyo today announced that the EMA has validated the type II variation application for Enhertu (trastuzumab deruxtecan) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 low (defined as IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (defined as IHC 0 with membrane staining) breast cancer who have received at least one endocrine therapy in the metastatic setting.
