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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.

References

  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. https://bit.ly/2pH1Dt4. 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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