FDA Accepts NDA for Neratinib in HER2+ Early Stage Breast Cancer

The U.S. Food and Drug Administration (FDA) accepted a New Drug Application for neratinib for the extended treatment of patients with early HER2-positive breast cancer in the adjuvant setting. Neratinib is intended only for patients who received prior adjuvant trastuzumab-based therapy.¹

The submission is based on findings from the phase 3 ExteNET study (Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer; ClinicalTrials.gov Identifier: NCT00878709), which were published in The Lancet Oncology in February, 2016.

Treatment with neratinib reduced the risk of invasive disease recurrence or death by 33%, in contrast with placebo among women with early stage HER2-positive breast cancer (hazard ratio, 0.67; P = .009). The 2-year invasive disease free survival rate with neratinib and placebo were 93.9% and 91.6%, respectively.

Among patients with hormone receptor-positive disease, adjuvant treatment with neratinib led to a 49% reduction in the risk of invasive disease recurrence or death versus placebo (hazard ratio, 0.51; P = .001). The 2-year invasive disease-free survival rates among this pre-defined subgroup were 95.4% and 91.2% for neratinib and placebo, respectively.

The most common adverse event in neratinib-treated patients was diarrhea. Patients in the ExteNET trial did not, however, receive prophylactic antidiarrheal agents.          

Reference

1. Puma Biotechnology announces U.S. FDA acceptance of New Drug Application for PB272 (neratinib) for extended adjuvant treatment of her2-positive early stage breast cancer. Puma Biotechnology website. http://www.pumabiotechnology.com/pr20160920.html. Updated September 20, 2016. Accessed September 21, 2016.