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NERLYNX + capecitabine protects against progression3

PFS IN PATIENTS WITH HER2+ mBC VS LAPATINIB

29% rate chart
  • NERLYNX + capecitabine significantly improved median PFS vs lapatinib + capecitabine: 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)3
  • Median overall survival trended in favor of NERLYNX + capecitabine in patients with HER2+ mBC: 21 months with NERLYNX + capecitabine vs 18.7 months with lapatinib + capecitabine (HR=0.88; 95% CI: 0.72, 1.07; P=0.2086)3

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

Select IMPORTANT SAFETY INFORMATION

Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

Lactation: Advise women not to breastfeed.

Please see additional IMPORTANT SAFETY INFORMATION below.

NERLYNX + capecitabine prevents tumor growth3,22

DURATION OF RESPONSE WAS LONGER WITH NERLYNX VS LAPATINIB

CI: confidence interval; HR: hazard ratio.

*Descriptive P value.

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

  • NERLYNX as a single agent: diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increased, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased, and urinary tract infection.

  • NERLYNX in combination with capecitabine: diarrhea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, weight decreased, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms.

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.