Regulatory approval
Published by the Health Service Executive.
The Republic of Ireland's Health Service Executive (HSE) has approved abemaciclib in combination with endocrine therapy for reimbursement as a treatment option for the adjuvant treatment of hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence in adult patients. According to the European Medicine Agency's product information for abemaciclib, this indication was approved based on results from the monarchE study, a randomized, open label, two cohort, phase 3 study which enrolled a total of 5,637 patients who were randomized in a 1:1 ratio to receive 2 years of abemaciclib plus physician's choice of standard endocrine therapy, or standard endocrine therapy alone.
This is written in the approval document as:
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.
Citation
Abemaciclib Therapy, 2024, version number 1, NCCP National SACT Regimen, NCCP, viewed 21/07/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/breast/619-abemaciclib-therapy.pdf
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Type |
Biomarker(s) |
Cancer type |
Therapy(ies) |
|
| Sensitivity (+) |
ER positive,
HER2-negative,
PR positive
|
Invasive Breast Carcinoma |
Abemaciclib,
Exemestane
|
|
| Sensitivity (+) |
ER positive,
HER2-negative
|
Invasive Breast Carcinoma |
Abemaciclib,
Exemestane
|
|
| Sensitivity (+) |
HER2-negative,
PR positive
|
Invasive Breast Carcinoma |
Abemaciclib,
Exemestane
|
|
| Sensitivity (+) |
ER positive,
HER2-negative
|
Invasive Breast Carcinoma |
Abemaciclib,
Tamoxifen
|
|
| Sensitivity (+) |
HER2-negative,
PR positive
|
Invasive Breast Carcinoma |
Abemaciclib,
Tamoxifen
|
|
| Sensitivity (+) |
ER positive,
HER2-negative,
PR positive
|
Invasive Breast Carcinoma |
Abemaciclib,
Tamoxifen
|
|
| Sensitivity (+) |
ER positive,
HER2-negative,
PR positive
|
Invasive Breast Carcinoma |
Abemaciclib,
Letrozole
|
|
| Sensitivity (+) |
ER positive,
HER2-negative
|
Invasive Breast Carcinoma |
Abemaciclib,
Letrozole
|
|
| Sensitivity (+) |
HER2-negative,
PR positive
|
Invasive Breast Carcinoma |
Abemaciclib,
Letrozole
|
|
| Sensitivity (+) |
ER positive,
HER2-negative,
PR positive
|
Invasive Breast Carcinoma |
Abemaciclib,
Letrozole
|
|
| Sensitivity (+) |
ER positive,
HER2-negative
|
Invasive Breast Carcinoma |
Abemaciclib,
Letrozole
|
|
| Sensitivity (+) |
HER2-negative,
PR positive
|
Invasive Breast Carcinoma |
Abemaciclib,
Letrozole
|
|