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FDA Updates Neratinib Label in HER2+ Breast Cancer

Gina Columbus @ginacolumbusonc
Published: Thursday, Oct 03, 2019

The FDA has approved a labeling supplement for neratinib (Nerlynx) for the extended adjuvant treatment of patients with HER2-positive early-stage breast cancer.1

There were no fatal adverse events and 2 grade 4 treatment-emergent AEs, which was due to sepsis.


  1. FDA Approves Labeling Supplement for Puma Biotechnology’s NERLYNX® (neratinib) for the Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer. Puma Biotechnology. Published October 2, 2019. Accessed October 3, 2019.    
  2. Hurvitz SA, Chan A, Iannotti NO, et al. Effects of adding budesonide or colestipol to loperamide prophylaxis on neratinib-associated diarrhea in patients with HER2+ early-stage breast cancer: the CONTROL trial. Presented at: 2017 San Antonio Breast Cancer Symposium; December 5-9, 2017; San Antonio, TX. Abstract P3-14-01.
  3. Barcenas CH, Hurvitz SA, Di Palma JA, et al. Effect of prophylaxis on neratinib-associated diarrhea and tolerability in patients with HER2+ early-stage breast cancer: Phase II CONTROL trial. J Clin Oncol. 2019;37(suppl; abstr 548). doi: 10.1200/JCO.2019.37.15_suppl.548.

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