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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)‡
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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.

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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.

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Reference:

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  2. Martin M, Holmes FA, Ejlertsen B, et al. Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2017;18(12):1688-1700.
  3. NERLYNX [package insert]. Los Angeles, CA: Puma Biotechnology, Inc.
  4. Cameron D, Piccart-Gebhart MJ, Gelber RD, et al. 11 years’ follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the HERceptin Adjuvant (HERA) trial. Lancet. 2017;389(10075):1195-1205.
  5. Perez EA, Romond EH, Suman VJ, et al. Trastuzumab plus adjuvant chemotherapy for human epidermal growth factor receptor 2-positive breast cancer: planned joint analysis of overall survival from NSABP B-31 and NCCTG N9831. J Clin Oncol. 2014;32(33):3744-3752.
  6. Yee D. Pathological complete response predicts event-free and distant disease free survival in the I-SPY 2 TRIAL. Slides presented at: 2017 San Antonio Breast Cancer Symposium (SABCS); December 5-9, 2017; San Antonio, TX.
  7. Recurrent breast cancer. Mayo Clinic website. https://www.mayoclinic.org/diseases-conditions/ recurrent-breast-cancer/symptoms-causes/syc-20377135. Accessed July 27, 2020.
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  9. Pierce JP, Patterson RE, Senger CM, et al. Lifetime cigarette smoking and breast cancer prognosis in the After Breast Cancer Pooling Project. J Natl Cancer Inst. 2014;106(1):djt359.
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  12. Singh JC, Jhaveri K, Esteva FJ. HER2-positive advanced breast cancer: optimizing patient outcomes and opportunities for drug development. Br J Cancer. 2014;111(10):1888-1898.
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  14. Slamon D, Eiermann W, Robert N, et al. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011;365(14):1273-1283.
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  17. Lin NU. Breast cancer brain metastases: new directions in systemic therapy. Ecancermedicalscience. 2013;7:307.
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  21. Puma Biotechnology, Inc. Data on file
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  27. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers V.2.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed July 24, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org.
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  39. Giuliano M, Trivedi MV, Schiff R. Bidirectional crosstalk between the estrogen receptor and human epidermal growth factor receptor 2 signaling pathways in breast cancer: molecular basis and clinical implication. Breast Care. 2013;8:256-262.
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