ERBB2 and breast cancer: Based on these results, abemaciclib received FDA approval in 2021 as adjuvant therapy for women with high-risk, node-positive, hormone receptor positive, HER2-negative BC with Ki-67 ≥ 20% with one of the following features: (i) N1 disease and other high-risk features (T3, high grade) or (ii) N2 or N3 disease.