> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Puma Biotech Labeling Supplement for Nerlynx
- URL: https://www.fdaweb.com/puma-biotech-labeling-supplement-for-nerlynx/
- Published: 2019-10-02T12:00:00.000Z
- Updated: 2026-09-15T01:53:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145155

FDA has approved a Puma Biotechnology labeling supplement for Nerlynx (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer. The label now includes safety information that is based on interim results from Puma’s Phase 2 CONTROL trial, a study evaluating dose escalation in reducing neratinib-associated diarrhea. “Interim data from the trial showed that the addition of prophylactic treatment with loperamide plus budesonide reduced the discontinuation rate due to neratinib-associated diarrhea to 11% versus a discontinuation rate of 18% with loperamide alone,” the company said.