Harpreet Singh, Amanda J Walker, Laleh Amiri-Kordestani, Joyce Cheng, Shenghui Tang, Pamela Balcazar, Kimberly Barnett-Ringgold, Todd R Palmby, Xianhua Cao, Nan Zheng, Qi Liu, Jingyu Yu, William F Pierce, Selena R Daniels, Rajeshwari Sridhara, Amna Ibrahim, Paul G Kluetz, Gideon M Blumenthal, Julia A Beaver, Richard Pazdur
On July 17, 2017, the Food and Drug Administration (FDA) approved neratinib (NERLYNX, Puma Biotechnology, Inc) for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy. Approval was based on data from ExteNET, a randomized, double-blind, placebo-controlled multicenter trial. Women with early-stage HER2-positive breast cancer and within two years of completing adjuvant trastuzumab were randomized to neratinib (n=1420) or placebo (n=1420) for one year...
March 9, 2018: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research