European regulators have recommended against approving a marketing authorization application (MAA) for the use of neratinib (Nerlynx) as extended adjuvant treatment for women with early stage HER2-positive breast cancer.
The rate of dose reductions (7.3% vs 26.4%) and holds (14.6% vs 33.9%) due to diarrhea were lower in the patients who received loperamide. However, the rate of discontinuation due to diarrhea was higher in the loperamide cohort at 20.4% versus 16.8% with neratinib alone.
- Martin M, Holmes FA, Ejlertsen B, et al. Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2017; 18:1688-700.
- Puma Biotechnology presents interim results of phase II CONTROL Trial of PB272 in extended adjuvant treatment of her2-positive early stage breast cancer at the 2017 AACR Annual Meeting. Posted April 4, 2017. Accessed February 23, 2018. http://bit.ly/2EXiduL.
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