18 October 2024 - Recommendation is based on the Phase 3 NATALEE trial, where Kisqali added to endocrine therapy significantly reduced the risk of recurrence by 25% versus endocrine therapy alone across a broad population of patients with HR+/HER2- early breast cancer.

Novartis announced today that the CHMP of the EMA has adopted a positive opinion and recommended granting marketing authorisation for Kisqali (ribociclib) 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.

Read Novartis press release