The FDA approved abemaciclib (Verzenio, Lilly) with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of adults who have hormone receptor (HR)-positive, HER2-negative, node-positive, early breast cancer at high risk for recurrence and a Ki-67 score of 20% or higher, as determined by an FDA-approved test.
The agency also approved the Ki-67 IHC MIB-1 pharmDx (Dako Omnis, Agilent) assay as a companion diagnostic for selecting patients for this