• Guideline recommendations for Nerlynx®

    Neratinib (Nerlynx) is included as a treatment option for HER2+ eBC in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer1

    NCCN Guidelines® Inclusions

    Useful in certain circumstances for patients with HER2+ eBC1

    Category 2A*

    Consider extended adjuvant neratinib (Nerlynx) following adjuvant trastuzumab-containing therapy for patients with HER2+ HR+ eBC with a perceived high risk of recurrence1,†

    ExteNET (NCT00878709)

    Dose escalation

    The NCCN Guidelines recommend dose escalation of neratinib (Nerlynx)1

    CONTROL (NCT02400476)

    • Category 2A: Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate.1
    • The benefits or toxicities associated with extended neratinib in patients who have received pertuzumab are unknown.1
    • eBC: early-stage breast cancer; HR+: hormone receptor–positive.
    NCCN makes no warranties of any kind whatsoever regarding its content, use, or application and disclaims any responsibility for how its content is applied or used, in any way.

    Neratinib (Nerlynx) is included as part of 2 treatment options for recurrent HER2+ breast cancer CNS metastases in the NCCN Guidelines for Central Nervous System Cancers2

    NCCN Guidelines Inclusions

    Category 2A*: recommended for brain metastases2

    Phase 3 trial†

    Consider neratinib (Nerlynx) + capecitabine to treat patients with stable, asymptomatic HER2+ breast cancer brain metastases2

    NALA (NCT01808573)

    Phase 2 trial‡

    Consider neratinib (Nerlynx) + capecitabine to treat patients with progressive HER2+ breast cancer brain metastases2

    TBCRC 022 (NCT01494662)

    • Category 2A: Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate.2
    • A phase 3 trial of neratinib + capecitabine vs lapatinib + capecitabine for patients with HER2+ breast cancer after >2 HER2-directed regimens in the metastatic setting.2,3
    • A phase 2 trial of neratinib and capecitabine for patients with HER2+ breast cancer and brain metastases.2
    • CNS: central nervous system.
    NCCN makes no warranties of any kind whatsoever regarding its content, use, or application and disclaims any responsibility for how its content is applied or used, in any way.
    The National Comprehensive Cancer Network® (NCCN®) Guidelines are produced completely independently. NCCN Guidelines are not intended to promote any specific therapeutic modality. They may contain information that may differ from or is not included in the Full Prescribing Information for neratinib (Nerlynx).
    References:
    1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.4.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed July 12, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org.
    2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers V.1.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed July 12, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org.
    3. Saura C, Oliveira M, Feng Y-H, et al. Neratinib plus capecitabine versus lapatinib plus capecitabine in HER2-positive metastatic breast cancer previously treated with ≥ 2 HER2-directed regimens: phase III NALA trial. J Clin Oncol. 2020;38(27):3138-3149. doi:10.1200/JCO.20.00147

    Important Safety Information

    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.

    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.

    Important Safety Information

    Warnings and Precautions:

  • Diarrhea: Manage diarrhea through either Nerlynx dose escalation or loperamide prophylaxis...

    • Warnings and Precautions:

    • 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:

    • 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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    PRC-US-NER-3302 09/25