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EMA Recommends Extension of Therapeutic Indications for Abemaciclib

New indication concerns the use in patients with early breast cancer at high risk of recurrence
10 Mar 2022
Anticancer agents & Biologic therapy;  Breast cancer

On 24 February 2022, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product abemaciclib (Verzenios).

The marketing authorisation holder for this medicinal product is Eli Lilly Nederland B.V..

The CHMP adopted an extension to the existing indication to include use in patients with early breast cancer at high risk of recurrence.

For information, the full indication for Verzenios will be as follows (new text in bold):

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.

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 HR-positive, 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.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.  

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