FDA Approves Neratinib for Extended Adjuvant Treatment of Early-Stage HER2-Positive Breast Cancer

Today, the U.S. Food and Drug Administration approved neratinib (Nerlynx) for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab (Herceptin)-based therapy.

ExteNET Trial

Approval was based on the ExteNET trial, a multicenter, randomized, double-blind, placebo-controlled trial of neratinib following adjuvant trastuzumab treatment. Women (N = 2,840) with early-stage HER2-positive breast cancer and within 2 years of completing adjuvant trastuzumab were randomized to receive either neratinib (n = 1,420) or placebo (n = 1,420) for 1 year.

The major efficacy outcome measure was invasive disease-free survival, defined as the time between the randomization date to the first occurrence of invasive recurrence (local/regional, ipsilateral, or contralateral breast cancer), distant recurrence, or death from any cause, within 2 years and 28 days of follow-up. After 2 years, the invasive disease-free survival rate was 94.2% in patients treated with neratinib compared with 91.9% in those receiving placebo (hazard ratio = 0.66; 95% confidence interval = 0.49–0.90, P = .008).

The most common adverse reactions (> 5%) were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, aspartate transaminase or alanine transaminase increase, nail disorder, dry skin, abdominal distention, weight loss, and urinary tract infection. The most common adverse reaction leading to discontinuation was diarrhea, observed in 16.8% of neratinib-treated patients. Hepatotoxicity or increases in liver transaminases led to drug discontinuation in 1.7% of neratinib-treated patients.

The recommended dose of neratinib is 240 mg (6 tablets) given orally once daily with food, continuously for 1 year. Antidiarrheal prophylaxis should be initiated with the first neratinib dose and continued during the first 2 cycles (56 days) of treatment and as needed thereafter.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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