The US Food and Drug Administration (FDA) approved neratinib as an extended adjuvant treatment for patients who initially received adjuvant trastuzumab-based therapy to treat early-stage HER2-overexpressed/amplified breast cancer.1
The FDA based its approval on data from the double-blinded ExteNET Trial (ClinicalTrials.gov Identifier: NCT00878709), which randomly assigned 2840 women with early-stage disease who completed adjuvant trastuzumab within 2 years to receive placebo or neratinib for 1 year.
The primary efficacy outcome was invasive disease–free survival (iDFS).
Patients treated with neratinib had an iDFS of 94.2% vs 91.9% in patients who received placebo (hazard ratio [HR], 0.66; 95% CI, 0.49-0.90; P = .008) after 2 years.
The most frequently reported adverse event (AE) that led to discontinuation of therapy was diarrhea at 16.8%.
Other frequently observed AEs included nausea, vomiting, abdominal pain, fatigue, decreased appetite, stomatitis, dyspepsia, abdominal distension, and weight loss.
- FDA approves neratinib for extended adjuvant treatment of early stage HER2-positive breast cancer [press release]. Silver Spring, MD: US Food and Drug Administration; July 17, 2017. https://www.fda.gov/Drugs/InformationOnDrugs/ ApprovedDrugs/ucm567259.htm. Accessed July 17, 2017.