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NERLYNX + capecitabine protects against progression3

PFS IN PATIENTS WITH HER2+ mBC VS LAPATINIB + CAPECITABINE

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

*Exploratory analysis.

The total number of patients remaining in study at 24 months was 11 (9 patients receiving NERLYNX + capecitabine, 2 patients receiving lapatinib + capecitabine).

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

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ADVERSE REACTIONS:

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

  • 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.

NERLYNX + capecitabine prevents tumor growth3,26

DURATION OF RESPONSE WAS LONGER WITH NERLYNX + CAPECITABINE VS LAPATINIB + CAPACITABINE3,26

*Descriptive P value.

CI: confidence interval; HR: hazard ratio.

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Drug interactions: 1. Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors. When patients require gastric acid reducing agents, use an H2-receptor antagonist or antacid. Separate NERLYNX by at least 3 hours with antacids. Separate NERLYNX by at least 2 hours before or 10 hours after H2-receptor antagonists. 2. Strong CYP3A4 inhibitors: Avoid concomitant use. 3. Moderate CYP3A4 and P-glycoprotein (P-gp) dual inhibitors: Avoid concomitant use. 4. Strong or moderate CYP3A4 inducers: Avoid concomitant use. 5. P-glycoprotein (P-gp) substrates: Monitor for adverse reactions of narrow therapeutic agents that are P-gp substrates when used concomitantly with NERLYNX.

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.