The Food and Drug Administration (FDA) has approved Nerlynx (neratinib; Puma Biotechnology) for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy.

The approval was supported by data from the multicenter, randomized, double-blind, placebo-controlled trial (n=2,840), ExteNET, which evaluated neratinib following adjuvant trastuzumab treatment. Female patients with early stage HER2-positive breast cancer were randomized to either neratinib or placebo for 1 year. 

The study’s main efficacy outcome measure was invasive disease-free survival (iDFS), which was measured as the time between the randomization date to the first occurrence of invasive recurrence, distant recurrence, or all-cause mortality within 2 years and at 28 days of follow-up. The iDFS was reportedly 94.2% in Nerlynx-treated patients vs. 91.9% in placebo patients after 2 years (hazard ratio [HR] 0.66, 95% CI: 0.49, 0.90; P=0.008).  

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Diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST/ALT increase, nail disorder, dry skin, abdominal distension, weight loss, and urinary tract infection were the most commonly reported adverse reactions. Antidiarrheal prophylaxis is recommended with the first dose of Nerlynx, during the first two cycles of treatment, and as required thereafter. 

Nerlynx is a kinase inhibitor that binds irreversibly to epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 2 (HER2), and HER4. In vivo, oral administration resulted in inhibition of tumor growth with tumor cell lines expressing HER2 and EGFR. 

“HER2-positive breast cancers are aggressive tumors and can spread to other parts of the body, making adjuvant therapy an important part of the treatment plan,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Now, these patients have an option after initial treatment that may help keep the cancer from coming back.”  

Nerlynx will be available as 40mg strength tablets in 126- and 180-count bottles.

For more information call (844) 637-5969 or visit