• Indications: Nerlynx® (neratinib) tablets, for oral use, is a kinase inhibitor indicated:

    • As a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.
    • In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.

    • You may have patients like Mary

    She's worked hard to get this far

    Acting with urgency can help give patients with HER2+ eBC the chance to live disease free1
    Review the risk of recurrence
    Real patient with HER2+ HR+ breast cancer who had a pCR. NERLYNX was not commercially available at the time of treatment. Photograph taken April 2013.

    Clinical guidelines and recommendations

    Support and product access for patients

    Useful resources for your office and patients

    • The primary endpoint in ExteNET was iDFS at 2 years in the ITT population (N=2840): 94.2% with NERLYNX (95% CI: 92.6%-95.4%) vs 91.9% with placebo (95% CI: 90.2%-93.2%) (HR=0.66; 95% CI: 0.49-0.90; P =0.008)3
    • ExteNET was a pivotal phase 3, global, multicenter, randomized, double-blind, placebo-controlled study of NERLYNX 240 mg/day for 1 year (n=1420) vs placebo (n=1420) in patients with early-stage HER2+ breast cancer (N=2840)1

    See Mary's story

    • 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 75% of patients (2117/2840) reconsented. 95% of the patients with HER2+ HR+ disease had concomitant endocrine therapy. “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.1,2
    • The primary endpoint of ExteNET was iDFS at 2 years. Results for iDFS in the ITT population (N=2840): 94.2% (95% CI: 92.6%-95.4%) with Nerlynx vs 91.9% (95% CI: 90.2%-93.2%) with placebo (HR=0.66; 95% CI: 0.49-0.90; P=0.008).3
    • Control was a phase 2, open-label, multicohort, multinational study that evaluated the effect of dose escalation or antidiarrheal prophylaxis on diarrhea associated with Nerlynx. Nerlynx dose-escalation arm DE1: n=60; 120 mg/day on days 1-7, 160 mg/day on days 8-14, 240 mg/day on days 15-364.4 There was an additional Nerlynx dose-escalation arm, DE2, studied in Control. Data from DE2 are not included in the USPI.4 ExteNET was a pivotal phase 3, global, multicenter, randomized, double-blind, placebo-controlled study. Nerlynx arm in ExteNET: n=1408; 240 mg/day for up to 1 year. Antidiarrheals were not protocol mandated.1,3
    • CI: confidence interval; CNS: central nervous system; eBC: early-stage breast cancer; HR: hazard ratio; HR+: hormone receptor–positive; iDFS: invasive disease–free survival; ITT: intent to treat; mBC: metastatic breast cancer; pCR: pathologic complete response.
    References:
    1. Chan A, Moy B, Mansi J, et al. Final efficacy results of neratinib in HER2-positive hormone receptor-positive early-stage breast cancer from the phase III ExteNET trial. Clin Breast Cancer. 2021;21(1):80-91.e7. doi:10.1016/j.clbc.2020.09.014
    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. doi:10.1016/S1470-2045(17)30717-9
    3. Nerlynx [package insert]. Los Angeles, CA: Puma Biotechnology, Inc.
    4. Chan A, Ruiz-Borrego M, Marx G, et al. Final findings from the Control trial: strategies to reduce the incidence and severity of neratinib-associated diarrhea in patients with HER2-positive early-stage breast cancer. Breast. 2023;67:94-101. doi:10.1016/j.breast.2022.12.003

    Important Safety Information and Indications

    Contraindications: None

    Warnings and Precautions:

    • Diarrhea: Manage diarrhea through either Nerlynx dose escalation or loperamide prophylaxis. If diarrhea occurs despite recommended prophylaxis, treat with additional antidiarrheals, 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.
    • Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated. Withhold Nerlynx in patients experiencing Grade 3 liver abnormalities and permanently discontinue Nerlynx in patients experiencing Grade 4 liver abnormalities.
    • Embryo-Fetal Toxicity: Nerlynx can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

    Adverse Reactions: 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.

    To report suspected adverse reactions, contact Puma Biotechnology, Inc. at 1-844-Nerlynx (1-844-637-5969) or FDA at 1-800-332-1088 or www.fda.gov/medwatch.

    Drug Interactions:

    • Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors. Separate Nerlynx by at least 2 hours before or 10 hours after H2-receptor antagonists. Or separate Nerlynx by at least 3 hours after antacids.
    • Strong CYP3A4 inhibitors: Avoid concomitant use.
    • P-gp and moderate CYP3A4 dual inhibitors: Avoid concomitant use.
    • Strong or moderate CYP3A4 inducers: Avoid concomitant use.
    • Certain P-gp substrates: Monitor for adverse reactions of P-gp substrates for which minimal concentration change may lead to serious adverse reactions when used concomitantly with Nerlynx.

    Use In Specific Populations:

    • Lactation: Advise women not to breastfeed.

    Please see Full Prescribing Information.

    Indications: Nerlynx® (neratinib) tablets, for oral use, is a kinase inhibitor indicated:

    • As a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.
    • In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.
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