Posted by Michael Wonder on 01 Oct 2024
Enhertu granted priority review in the US for patients with HER2 low or HER2 ultra-low metastatic breast cancer who have received at least one line of endocrine therapy
1 October 2024 - Based on DESTINY-Breast06 phase 3 trial which demonstrated a statistically significant and clinically meaningful progression-free survival benefit for Enhertu.
Daiichi Sankyo and AstraZeneca's supplemental biologics license application for Enhertu (famtrastuzumab deruxtecan-nxki) has been accepted and granted priority review in the US for the treatment of adult patients with unresectable or metastatic 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.
