Fulvestrant

Fulvestrant (Faslodex, AstraZeneca AB) has 3 EU-approved indications in 1 tumour type. Each needs a biomarker result: Hormone receptor (3).
Approved indications of Fulvestrant
Biomarker requirementRegimenSettingConditions
Breast cancer3
Hormone receptor-positive
Monotherapy
1L
advanced
No prior endocrine therapy; Postmenopausal women
Hormone receptor-positive, HER2-negative
+ palbociclib
2L
advanced
After prior endocrine therapy; Women; In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a LHRH agonist
Hormone receptor-positive
Monotherapy
2L
advanced
Disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy; Postmenopausal women
Full text of section 4.1 (therapeutic indications)

Faslodex is indicated: • as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: - not previously treated with endocrine therapy, or - with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy. • in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy (see section 5.1). In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.

Label history

32 changes to the Faslodex label since 2004, 3 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes