Regulatory approval

Published by the Health Service Executive. Approved

Abemaciclib in combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence.

This is written in the approval document.

Reimbursement

CDS

Citation

Abemaciclib Therapy, 2025, version number 4, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6415/619_v4_Abemaciclib.pdf

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations Biomarkers Cancer types Therapies
HSE (1) ER positive, HER2-negative Invasive Breast Carcinoma Abemaciclib, Tamoxifen
HSE (1) HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Tamoxifen
HSE (1) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Tamoxifen
HSE (1) ER positive, HER2-negative Invasive Breast Carcinoma Abemaciclib, Anastrozole
HSE (1) HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Anastrozole
HSE (1) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Anastrozole
HSE (1) ER positive, HER2-negative Invasive Breast Carcinoma Abemaciclib, Letrozole
HSE (1) HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Letrozole
HSE (1) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Letrozole
HSE (1) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Exemestane
HSE (1) ER positive, HER2-negative Invasive Breast Carcinoma Abemaciclib, Exemestane
HSE (1) HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Exemestane