Faslodex (fulvestrant) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
FASLODEX is an estrogen receptor antagonist indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy.	3
FASLODEX is an estrogen receptor antagonist indicated for the treatment of HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy.	3
FASLODEX is an estrogen receptor antagonist indicated for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib, as initial endocrine based therapy or following disease progression on endocrine therapy.	3
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.	6

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
FDA (1)	ER positive, HER2-negative	Invasive Breast Carcinoma	Abemaciclib, Fulvestrant
FDA (1)	HER2-negative, PR positive	Invasive Breast Carcinoma	Abemaciclib, Fulvestrant
FDA (1)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Abemaciclib, Fulvestrant
FDA (1)	ER positive, HER2-negative	Invasive Breast Carcinoma	Fulvestrant
FDA (1)	HER2-negative, PR positive	Invasive Breast Carcinoma	Fulvestrant
FDA (1)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Fulvestrant
FDA (1)	ER positive	Invasive Breast Carcinoma	Fulvestrant
FDA (1)	PR positive	Invasive Breast Carcinoma	Fulvestrant
FDA (1)	ER positive, PR positive	Invasive Breast Carcinoma	Fulvestrant
FDA (1)	ER positive, HER2-negative	Invasive Breast Carcinoma	Fulvestrant, Ribociclib
FDA (1)	HER2-negative, PR positive	Invasive Breast Carcinoma	Fulvestrant, Ribociclib
FDA (1)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Fulvestrant, Ribociclib
FDA (1)	ER positive, HER2-negative	Invasive Breast Carcinoma	Fulvestrant, Palbociclib
FDA (1)	HER2-negative, PR positive	Invasive Breast Carcinoma	Fulvestrant, Palbociclib
FDA (1)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Fulvestrant, Palbociclib