Novartis Announces Positive CHMP Opinion for Kisqali

BASEL (dpa-AFX) – Novartis announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion and recommended the granting of marketing authorization for Kisqali for the adjunctive treatment of adults with positive hormone receptor/factor human epidermal growth receptor 2-negative early breast cancer, with a high risk of disease recurrence, including those with node-negative disease. The recommendation is based on the Phase III NATALEE trial. The European Commission will make a final decision within approximately two months.

Patrick Horber, International President of Novartis, said: “Together with the recent FDA approval and NATALEE’s latest data presented at ESMO, today’s positive recommendation from the CHMP further reinforces Kisqali’s differentiated profile as a new treatment option. for a broad patient population, including those with node-negative disease.

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