FDA Approves AstraZeneca’s Enhertu as First Targeted Therapy for HER2-low Cancer
Enhertu, developed by AstraZeneca and Daiichi Sankyo, has been approved by the FDA as the first targeted therapy for HER2-low breast cancer, a new subtype of the disease previously categorized as HER2-negative. It has the potential to be a significant new indication for Enhertu (trastuzumab deruxtecan), a HER2-targeting antibody-drug combination that is fundamental to AstraZeneca and Daiichi Sankyo's plans for multibillion-dollar sales. According to the FDA, under the existing classification system, between 80 and 85% of the over 290,000 new instances of breast cancer diagnosed in wome...