Posted by Michael Wonder on 19 Aug 2024
Enhertu granted breakthrough therapy designation in US for certain patients with HER2 low or HER2 ultralow metastatic breast cancer
19 August 2024 - Daiichi Sankyo and AstraZeneca's Enhertu has now been granted eight breakthrough therapy designations with latest based on DESTINY-Breast06 phase 3 trial results.
Enhertu (fam-trastuzumab deruxtecan-nxki) has been granted breakthrough therapy designation in the US for the treatment of unresectable or metastatic hormone receptor positive HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC >0 <1+) breast cancer patients who have received either two lines of endocrine therapy in the metastatic setting, or one line of endocrine therapy if they had demonstrated disease progression within six months of starting first-line treatment with endocrine therapy in combination with a CDK4/6 inhibitor or within 24 months of the start of adjuvant endocrine therapy.
