Enhertu (fam-trastuzumab deruxtecan-nxki) received FDA regular approval for adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within 6 months of completing therapy.
In patients with high-risk HER2-positive breast cancer, post-surgery, or adjuvant, treatment with trastuzumab emtansine, also referred to as T-DM1) reduced the long-term risk of death or invasive disease by 46% and improved survival compared to trastuzumab alone, according to the final results of the phase III KATHERINE clinical trial led by researchers from the University of Pittsburgh and UPMC Hillman Cancer Center.
