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    Association details:
    Biomarker:HER-2 overexpression
    Cancer:Hormone Receptor Positive Breast Cancer
    Drug:Nerlynx (neratinib) (EGFR inhibitor, HER2 inhibitor, HER4 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    Puma Biotech Press Release
    Title:

    Puma Biotechnology Licensing Partner Specialised Therapeutics Receives Marketing Approval in Malaysia for NERLYNX® (neratinib) for Extended Adjuvant Treatment of Early Stage HER2-Positive Breast Cancer

    Published date:
    07/16/2020
    Excerpt:
    Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that its licensing partner Specialised Therapeutics Asia (STA) has received marketing approval of NERLYNX® (neratinib) in Malaysia from the Drug Control Agency (DCA), under Malaysia’s Ministry of Health (MOH). NERLYNX is indicated for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy.
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    Knight Therapeutics Press Release
    Title:

    Knight Therapeutics Announces Health Canada Has Approved NERLYNX ® for Early-Stage Breast Cancer

    Published date:
    07/16/2019
    Excerpt:
    ...Knight Therapeutics Inc. (TSX:GUD) ("Knight"), a leading Canadian specialty pharmaceutical company, announced today that Health Canada has approved NERLYNX® (neratinib) for the extended adjuvant treatment of women with early-stage hormone receptor positive, HER2-overexpressed/amplified breast cancer within one year after completion of trastuzumab-based adjuvant therapy.
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    European Medicines Agency
    Published date:
    08/31/2018
    Excerpt:
    Nerlynx is indicated for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy.
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Lancet Oncol
    Title:

    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

    Published date:
    11/13/2017
    Excerpt:
    After a median follow-up of 5·2 years (IQR 2·1-5·3), patients in the neratinib group had significantly fewer invasive disease-free survival events than those in the placebo group (116 vs 163 events; stratified hazard ratio 0·73, 95% CI 0·57-0·92, p=0·0083).
    DOI:
    10.1016/S1470-2045(17)30717-9
    Trial ID:
    ExteNET
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Real-life Pan-HER-blockade With Neratinib

    Excerpt:
    ...- Hormone receptor (HR) positive, Human epidermal growth factor receptor 2 (HER2) overexpressing/amplified breast cancer stage I-III;...
    Trial ID:
    ELEANOR
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Neratinib +/- Fulvestrant in HER2+, ER+ Metastatic Breast Cancer

    Excerpt:
    ...- Participants must have documented HER2+ disease by overexpression and/or gene amplification on the most recent biopsy, per current ASCO-CAP (American Society of Clinical Oncology...
    Trial ID:
    NCT03289039
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Retrospective Observational Study of Patients With Early-stage HER2-positive Breast Cancer, Treated With Neratinib

    Excerpt:
    ...Age will be assessed in years = neratinib initiation date - date of birth`Description of age`Gender will be described in percentage of Male and Female among patients`Description of Gender`BMI will be assessed in kg/m2`Description of BMI`Menopausal status will be described in percentage of Premenopausal, Perimenopausal, Postmenopausal, Surgical/other reason for amenorrhea`Menopausal status`Comorbidities will be described in number and percentage of patients with at least one relevant comorbidity`Comorbidities`HER2 overexpression/amplification testing will be assessed by Immunohistochemistry (IHC), Fluorescence in situ hybridization (FISH), Chromogenic in situ hybridization (CISH)`HER2 overexpression/amplification testing`Hormone receptor status will be described in percentage of patients with Estrogen receptor (ER) positive, Progesterone receptor (PR) positive, ER and PR negative`Hormone receptor status`Primary tumor location will be described in percentage of patients with Left Breast cancer, Right Breast cancer`Primary tumor location`Primary tumor histology will be described in percentage of patients with Infiltrating ductal carcinoma, Infiltrating lobular carcinoma, Invasive carcinoma, Tubular, Other`Primary tumor histology`Histological grade will be described in percentage of patients with G1 Well differentiated, G2 Moderately differentiated, G3 Poorly differentiated, G4 Undifferentiated`Histological grade`Pathologic stage (AJCC classification) of Breast Cancer will be described in percentage of patients with stages 1, 2A, 2B, 3A, 3B, 3C`Pathologic stage (AJCC classification) of Breast Cancer...
    Trial ID:
    NEAR
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Future Oncol
    Title:

    Neratinib-based therapy in patients with metastatic HER2-positive breast cancer from Asia

    Published date:
    08/21/2019
    Excerpt:
    The overall response rate in patients from Asia was 66.4% (180/271) and the median progression-free survival was 55.6 weeks.
    Secondary therapy:
    Chemotherapy
    DOI:
    10.2217/fon-2019-0222