FDA Approves Neratinib for Extended Adjuvant Treatment of Breast Cancer

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.

Reference

1. 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.