FDA Accepts NDA for Neratinib in HER2+ Early Stage Breast Cancer
The FDA accepted a New Drug Application for neratinib for the extended treatment of patients with early HER2-positive 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.
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The most common adverse event in neratinib-treated patients was diarrhea. Patients in the ExteNET trial did not, however, receive prophylactic antidiarrheal agents.
- 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.