Created with sketchtool.

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

5.1%
ABSOLUTE
BENEFIT IN iDFS1,†,‡
4.7%
ABSOLUTE
BENEFIT IN DDFS1,†,‡

In HER2+, HR+ patients within 1 year of completing trastuzumab-based therapy vs placebo at 5 years1

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

DDFS: distant disease-free survival; HER2: human epidermal growth factor receptor 2; HR+: hormone receptor-positive; iDFS: invasive disease-free survival.

*Recurrence was defined as time from randomization to first occurrence of invasive ipsilateral tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence, or death from any cause.1 Distant recurrence is defined as the first occurrence of distant recurrence or death from any cause.2

95% of the HR+ study population received concurrent endocrine therapy.

Results of ExteNET are supported by an exploratory analysis of 5-year follow-up with 74.5% (2117/2840) of patients reconsented.2

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.