Fulvestrant
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| 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