University Hospital Erlangen

The CHMP of the EMA recommended marketing authorization for Kisqali (ribociclib) for adjuvant treatment of HR+/HER2- early breast cancer at high risk of recurrence, based on the NATALEE trial data showing a 25.1% reduction in recurrence risk. Kisqali, if approved, could expand treatment options for patients, including those with node-negative disease.

CHMP recommends Kisqali for adjuvant treatment of HR+/HER2- early breast cancer in Europe, based on NATALEE trial data showing 25% reduction in recurrence risk with Kisqali plus endocrine therapy versus endocrine therapy alone.

The CHMP recommends ribociclib (Kisqali) for adjuvant treatment of HR+/HER2- early breast cancer, based on NATALEE trial data showing a 25.1% reduction in recurrence risk. The European Commission will review the recommendation, with a decision expected within 2 months.

Novartis' Kisqali recommended by EMA for early breast cancer treatment, based on NATALEE Trial results showing 25.1% lower recurrence risk with Kisqali plus endocrine therapy vs. endocrine therapy alone. Kisqali already approved by FDA for early breast cancer and in 99 countries for metastatic breast cancer.

CHMP recommends Kisqali for adjuvant treatment of HR+/HER2- early breast cancer, based on NATALEE trial showing 25% reduced risk of recurrence with Kisqali + endocrine therapy vs. endocrine therapy alone. FDA approved Kisqali in this setting in September, with ESMO 2024 presenting updated NATALEE analysis showing deepened invasive disease-free survival benefit.

Kisqali (ribociclib) + endocrine therapy (ET) reduces recurrence risk by 28.5% beyond 3 years in HR+/HER2- early breast cancer, with consistent iDFS benefits across subgroups, including node-negative disease. Safety aligns with prior findings, and FDA action is expected in Q3.