Regulatory approval

Published by the Food and Drug Administration. Approved

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.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	ER positive, HER2-negative	Invasive Breast Carcinoma	Abemaciclib, Fulvestrant
FDA (2)	HER2-negative, PR positive	Invasive Breast Carcinoma	Abemaciclib, Fulvestrant
FDA (2)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Abemaciclib, Fulvestrant
FDA (2)	ER positive, HER2-negative	Invasive Breast Carcinoma	Fulvestrant, Palbociclib
FDA (2)	HER2-negative, PR positive	Invasive Breast Carcinoma	Fulvestrant, Palbociclib
FDA (2)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Fulvestrant, Palbociclib

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2017-08-25	Food and Drug Administration	Indication received traditional approval.