LOS ANGELES, Calif., Oct. 2, 2019 – Puma Biotechnology, Inc. (NASDAQ: PBYI) announced that the U.S. Food and Drug Administration (FDA) has approved a labeling supplement for NERLYNX® (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer. With the approval of the labeling supplement, the label now includes safety information based on interim results from Puma’s Phase II CONTROL Trial, a study evaluating antidiarrheal prophylaxis or dose escalation in the reduction of neratinib-associated diarrhea that has a primary endpoint of the incidence of grade 3 or higher diarrhea. Interim data from the trial showed that the addition of prophylactic treatment with loperamide plus budesomide reduced the discontinuation rate due to neratinib-associated diarrhea to 11% versus a discontinuation rate of 18% with loperamide alone. READ MORE