Created with sketchtool.

Reduce the risk of recurrence in early-stage HER2+ breast cancer1,2,*

7.4%
ABSOLUTE
BENEFIT IN iDFS
at 5 years vs placebo1,†
9.1%
ABSOLUTE
BENEFIT IN OS
at 8 years vs placebo1,‡,§

Descriptive analyses: HER2+ HR+ patients who completed prior trastuzumab-based therapy ≤1 year from randomization and did not achieve a pCR (n=295)1

See Study Design Explore Study Results View Safety Profile Get Dosing Information NCCN Guidelines®

*Results of ExteNET are supported by descriptive analyses after 5 years of follow-up, with 74.5% of patients (2117/2840) reconsented. 95% of the HR+ study population received concurrent endocrine therapy. Data in HER2+ HR+ patients who did not achieve a pCR were derived from a descriptive subgroup analysis.1,2

The primary endpoint of ExteNET was iDFS. Results for iDFS in the ITT population (N=2840): 94.2% (95% CI: 92.6%-95.4%) with NERLYNX vs 91.9% (95% CI: 90.2%-93.2%) with placebo at 2 years (HR=0.66; 95% CI: 0.49-0.90; P=0.008).3

After a median follow-up of 8 years, there was no statistically significant difference in OS between NERLYNX and placebo (HR=0.95; 95% CI: 0.75-1.21). The 5-year estimate of OS was 94.1% (95% CI: 92.7%-95.3%) with NERLYNX and 93.3% (95% CI: 91.8%-94.5%) with placebo.3

§HR=0.47 (95% CI: 0.23-0.92).1

CI: confidence interval; HER: human epidermal growth factor receptor; HR: hazard ratio; HR+: hormone receptor-positive; iDFS: invasive disease-free survival; ITT: intent to treat; OS: overall survival; pCR: pathologic complete response.

Select IMPORTANT SAFETY INFORMATION

Diarrhea: Aggressively manage diarrhea. If diarrhea occurs despite recommended prophylaxis, treat with additional anti-diarrheals, fluids, and electrolytes as clinically indicated. Withhold NERLYNX in patients experiencing severe and/or persistent diarrhea. Permanently discontinue NERLYNX in patients experiencing Grade 4 diarrhea or Grade ≥2 diarrhea that occurs after maximal dose reduction.

Please see additional IMPORTANT SAFETY INFORMATION below.

IMPORTANT SAFETY INFORMATION

NERLYNX® (neratinib) tablets, for oral use

INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated:

CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:

ADVERSE REACTIONS: The most common adverse reactions (reported in ≥5% of patients) were:

To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS:

USE IN SPECIFIC POPULATIONS:

For Full Prescribing Information, please click here.