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FDA approves Nerlynx for adjuvant treatment of HER-2-positive breast cancer
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The FDA today approved neratinib for extended adjuvant treatment of adults with early-stage HER-2-positive breast cancer who completed adjuvant trastuzumab-based therapy.
Neratinib (Nerlynx, Puma Biotechnology) is an oral, irreversible tyrosine kinase inhibitor.
The FDA based the approval on results of the ExteNET trial, a randomized, double-blind, placebo-controlled trial that included 2,840 women with early-stage HER-2-positive breast cancer. All women had completed adjuvant trastuzumab (Herceptin, Genentech) therapy within the prior 2 years.
Researchers randomly assigned the women 1:1 to neratinib or placebo.
Invasive DFS — defined as the time between randomization to invasive recurrence, distant recurrence or death from any cause — served as the primary efficacy endpoint.
At 2 years, researchers reported a higher invasive DFS rate among neratinib-treated patients (94.2% vs. 91.9%; HR = 0.66; 95% CI, 0.49-0.9).
The most frequent adverse reactions that occurred among at least 5% of study participants included diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, elevated alanine transaminase or aspartate transaminase levels, nail disorders, dry skin, abdominal distention, weight loss and urinary tract infection.
Nearly 17% of neratinib-treated patients discontinued treatment due to diarrhea, and 1.7% discontinued due to hepatotoxicity or increases in liver transaminases.