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EMA Adopts an Extension to the Existing Indication for Ribociclib

CHMP post-authorisation summary of positive opinion
21 Nov 2018
Breast cancer;  Anticancer agents & Biologic therapy

On 15 November 2018, 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 as follows (new text in bold): 

Kisqali 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 luteinising hormone releasing hormone (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.

Last update: 21 Nov 2018

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