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PREVENT RECURRENCE1,2,*

(Reduce the risk of recurrence in HER2+ eBC)
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PROTECT AGAINST PROGRESSION3

(Increase PFS in HER2+ mBC)
Explore the study

SHE’S WORKED HARD TO GET THIS FAR. CONTINUE TO TAKE EVERY OPPORTUNITY TO TREAT HER2+ DISEASE.

Real patient with HER2+ HR+ breast cancer. Not treated with NERLYNX.
Photograph taken April 2013.

the FIRST AND only HER2-directed small molecule approved in both early-stage and metastatic HER2+ breast cancer

*In patients randomized to NERLYNX ≤1 year from completing trastuzumab-based therapy. Results of ExteNET are supported by descriptive analyses after 5 years of follow-up, with 74.5% (2117/2840) of patients reconsented. 95% of the HR+ study population received concurrent endocrine therapy. Recurrence is 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.

5.1% absolute benefit in invasive disease-free survival vs placebo at 5 years in early-stage HER2+ HR+ breast cancer patients who were randomized within 1 year of completing trastuzumab-based therapy (HR=0.58; 95% CI: 0.41, 0.82; 2-sided P=0.002).

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; eBC: early breast cancer; HER: human epidermal growth factor receptor; HR: hazard ratio; HR+: hormone receptor–positive; mBC: metastatic breast cancer; PFS: progression-free survival.

DOSING AND ADMINISTRATION GUIDE

Learn about dose modifications, diarrhea management, and drug interactions with NERLYNX.

Patient Access and Support

See what services are available for your patients.

Resources

Helpful information and tools for you and your patients.

Select IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS:

  • Diarrhea: Aggressively manage diarrhea. If diarrhea occurs despite recommended prophylaxis, treat with additional anti-diarrheals, fluids, and electrolytes as clinically indicated.
  • Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated.
  • Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

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.