Palbociclib
Palbociclib (Ibrance, Pfizer Europe MA EEIG) has 2 EU-approved indications in 1 tumour type. Each needs a biomarker result: Hormone receptor (2).
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Breast cancer2 | |||
Hormone receptor-positive, HER2-negative | + fulvestrant | 2L advanced | After prior endocrine therapy; Women; in pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist |
Hormone receptor-positive, HER2-negative | + an aromatase inhibitor | Any line advanced | In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist |
Full text of section 4.1 (therapeutic indications)
IBRANCE is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer: - in combination with an aromatase inhibitor; - in combination with fulvestrant in women who have received prior endocrine therapy (see section 5.1). In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist.
Label history
27 changes to the Ibrance label since 2018, none of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes