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EMA Recommends Extension of Indications for Ribociclib to Include Use in Patients with Early Breast Cancer

New indication concerns the treatment of patients with early breast cancer at high risk of recurrence
05 Nov 2024
Targeted Therapy;  Endocrine Therapy
Breast Cancer

On 17 October 2024, 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 ribociclib (Kisqali).

The marketing authorisation holder for this medicinal product is Novartis Europharm Limited.

The CHMP adopted an extension to the existing indication to include use of Kisqali in patients with early breast cancer at high risk of recurrence, as follows:

Early breast cancer

Kisqali in combination with an aromatase inhibitor is indicated for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer at high risk of recurrence.

In pre- or perimenopausal women, or in men, the aromatase inhibitor should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.

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

Early breast cancer

Kisqali in combination with an aromatase inhibitor is indicated for the adjuvant treatment of patients with HR-positive, HER2-negative early breast cancer at high risk of recurrence.

In pre- or perimenopausal women, or in men, the aromatase inhibitor should be combined with a LHRH agonist.

Advanced or metastatic breast cancer

Kisqali 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 made 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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