Novartis Announces Positive CHMP Opinion For Kisqali - Quick Facts

(RTTNews) - Novartis announced the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion and recommended granting marketing authorization for Kisqali for the adjuvant treatment of adults with hormone receptor-positive/human epidermal growth factor receptor 2-negative early breast cancer, at 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 take a final decision within approximately two months.

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

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