Abemaciclib

Abemaciclib (Verzenios, Eli Lilly Nederland B.V.) has 3 EU-approved indications in 1 tumour type. Each needs a biomarker result: Hormone receptor (3).
Approved indications of Abemaciclib
Biomarker requirementRegimenSettingConditions
Breast cancer3
Hormone receptor-positive, HER2-negative
+ endocrine therapy
Adj.
early
Node-positive; high risk of recurrence; In pre- or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist
Hormone receptor-positive, HER2-negative
+ an aromatase inhibitor or fulvestrant
1L
advanced
Women; In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist
Hormone receptor-positive, HER2-negative
+ an aromatase inhibitor or fulvestrant
2L
advanced
After prior endocrine therapy; Women; In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist
Full text of section 4.1 (therapeutic indications)

Early breast cancer Verzenios in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence (see section 5.1). In pre- or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. Advanced or metastatic breast cancer Verzenios is indicated for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist.

Label history

21 changes to the Verzenios label since 2019, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes