Regulatory approval
Published by the Food and Drug Administration.
The U.S. Food and Drug Administration granted approval to fulvestrant in combination with either palbociclib or abemaciclib for the treatment of patients who are women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer with disease after endocrine therapy.
This is written in the approval document as:
FASLODEX is an estrogen receptor antagonist indicated for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy.
Citation
AstraZeneca UK Limited. Faslodex (fulvestrant) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021344s044lbl.pdf. Revised January 2021. Accessed October 30, 2024.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 | 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 | |
| Sensitivity (+) | ER positive, HER2-negative | Invasive Breast Carcinoma | Abemaciclib, Fulvestrant | |
| Sensitivity (+) | HER2-negative, PR positive | Invasive Breast Carcinoma | Abemaciclib, Fulvestrant | |
| Sensitivity (+) | ER positive, HER2-negative, PR positive | Invasive Breast Carcinoma | Abemaciclib, Fulvestrant |