Regulatory approval
Published by the Health Service Executive.
The Republic of Ireland's Health Service Executive (HSE) has approved palbociclib in combination with fulvestrant as a treatment option for the treatment of patients who are women with (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have received prior endocrine therapy.
This is written in the approval document as:
Treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with fulvestrant in women who have received prior endocrine therapy
Citation
Palbociclib Therapy - 28 day, 2020, version number 4, NCCP National SACT Regimen, NCCP, viewed 01/04/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/breast/414-palbociclib-therapy-28-days.pdfTherapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | ER positive, HER2-negative | Invasive Breast Carcinoma | Fulvestrant, Palbociclib | |
| Sensitivity (+) | HER2-negative, PR positive | Invasive Breast Carcinoma | Fulvestrant, Palbociclib | |
| Sensitivity (+) | ER positive, HER2-negative, PR positive | Invasive Breast Carcinoma | Fulvestrant, Palbociclib |