Neratinib has been approved by the U.S. FDA for extended adjuvant treatment following trastuzumab-based therapy in early-stage HER2-positive breast cancer, and in combination with capecitabine for patients with advanced or metastatic HER2-positive disease who have received at least two prior anti-HER2 therapies [13,14]. The gene discussed is ERBB2; the disease is breast cancer.