FDA Approves New Option for Early Stage Breast Cancer

The US Food and Drug Administration recently approved Nerlynx (neratinib) as an extended adjuvant treatment following adjuvant trastuzumab-based therapy for adult patients with early stage HER2-overexpressed/amplified breast cancer.

Nerlynx consists of 6 oral tablets with a combined dose of 240 mg, which are recommended to be taken once a day with food continuously for 1 year. Antidiarrheal prophylaxis should be initiated with the first dose and continued during the first 56 days of treatment. Afterwards, patients can take antidiarrheal therapy as needed.

Approval for Nerlynx was based on data from a randomized placebo-controlled trial that included 2840 women with early stage HER2-postive breast cancer who had completed 2 years of adjuvant trastuzumab therapy. The women were divided evenly and randomly assigned to receive either neratinib or placebo for 1 year. After 2 years, the invasive disease-free survival was 94.2% among patients treated with neratinib compared with 91.9% among patients who received the placebo.

Common adverse reactions associated with treatment included diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, weight loss, and urinary tract infection.

In addition, 16.8% of patients discontinued treatment Nerlynx due to diarrhea, and 1.7% of patients discontinued treatment due to hepatotoxicity or increases in liver transmainases.

—Melissa Weiss


FDA approves neratinib for extended adjuvant treatment of early stage HER2-positive breast cancer [press release]. FDA. July 17, 2017. Accessed July 18, 2017.