FDA approves Enhertu as first HER2-directed therapy for breast cancer

Enhertu (fam-trastuzumab deruxtecan-nxki) demonstrated a highly statistically significant and clinically meaningful improvement in invasive disease-free survival in patients with a high risk of disease recurrence, according to results from DESTINY-Breast05 phase III trial. 

Positive results from the DESTINY-Breast11 phase III trial showed Enhertu (fam-trastuzumab deruxtecan-nxki) followed by paclitaxel, trastuzumab, and pertuzumab in the neoadjuvant setting demonstrated a statistically significant and clinically meaningful improvement in the pathologic complete response rate. 

Two years of adjuvant Verzenio (abemaciclib) plus endocrine therapy reduced the risk of death by 15.8% versus ET alone and resulted in sustained long-term improvements in invasive disease-free survival and distant relapse-free survival, in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, high-risk early breast cancer, according to the primary overall survival analysis of the phase III monarchE trial.