VERZENIO (Eli Lilly Australia Pty Ltd)
Product name
VERZENIO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
141 working days (255)
Active ingredients
abemaciclib
Registration type
NCE/NBE
Indication
VERZENIO (tablets) 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 or fulvestrant as initial endocrine-based therapy, or following prior endocrine therapy.
In pre- or peri-menopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.