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PROTECT AGAINST PROGESSION3,*

29% PFS rate at 12 months with NERLYNX + capecitabine

vs 15% with lapatinib + capecitabine3

In metastatic HER2+ breast cancer patients after ≥2 prior lines of HER2-directed therapy for mBC3

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

*Median PFS of 5.6 months with NERLYNX + capecitabine vs 5.5 months with lapatinib + capecitabine (HR=0.76; 95% CI: 0.63, 0.93; P=0.0059).

CI: confidence interval; HER2: human epidermal growth factor receptor 2; HR: hazard ratio; mBC: metastatic breast cancer; PFS: progression-free survival.

Select IMPORTANT SAFETY INFORMATION

Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated. Withhold NERLYNX in patients experiencing Grade 3 liver abnormalities and permanently discontinue NERLYNX in patients experiencing Grade 4 liver abnormalities.

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.