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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 at 2 years. 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 (HR=0.66; 95% CI: 0.49-0.90; P=0.008).3

At 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: Manage diarrhea through either NERLYNX dose escalation or loperamide prophylaxis. If diarrhea occurs despite recommended prophylaxis, treat with additional antidiarrheals, 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.

INDICATIONS: NERLYNX® (neratinib) tablets, for oral use, is a kinase inhibitor indicated:

IMPORTANT SAFETY INFORMATION

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:

Please see Full Prescribing Information.