Posted by Michael Wonder on 03 Oct 2019
FDA approves labeling supplement for Puma Biotechnology’s Nerlynx (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer
2 October 2019 - Interim data from the Phase II CONTROL Trial showed that the addition of prophylactic treatment with loperamide plus budesonide reduced the rate of discontinuation due to neratinib-associated diarrhoea to 11% versus a discontinuation rate of 18% with loperamide alone.
Puma Biotechnology announced that the U.S. FDA has approved a labelling 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 diarrhoea that has a primary endpoint of the incidence of grade 3 or higher diarrhoea.
Interim data from the trial showed that the addition of prophylactic treatment with loperamide plus budesonide reduced the discontinuation rate due to neratinib-associated diarrhoea to 11% versus a discontinuation rate of 18% with loperamide alone.
