The U.S. Food and Drug Administration approved Nerlynx (neratinib) for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.
Approval was based on the ExteNET trial (NCT00878709), a multicenter, randomized, double-blind, placebo-controlled trial of Nerlynx following adjuvant trastuzumab treatment. Women (n=2,840) with early-stage HER2-positive breast cancer and within two years of completing adjuvant trastuzumab were randomized to receive either Nerlynx (n=1420) or placebo (n=1420) for one year.
The major efficacy outcome measure was invasive disease-free survival (iDFS) 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 two years and 28 days of follow-up. After two years, iDFS was 94.2% in patients treated with Nerlynx compared with 91.9% in those receiving placebo (HR 0.66; 95% CI: 0.49, 0.90, p=0.008).
The most common adverse reactions were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, 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 treated patients.
The recommended dose is 240 mg (6 tablets) given orally once daily with food, continuously for one year. Antidiarrheal prophylaxis should be initiated with the first Nerlynx dose and continued during the first 2 cycles (56 days) of treatment and as needed thereafter.
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