Ribociclib

Novartis AG announced EMA's CHMP positive opinion for Kisqali (ribociclib) in HR+/HER2- early breast cancer, based on NATALEE trial data showing 25.1% lower risk of recurrence. The EC will decide in ~2 months.

EMA's CHMP supports approval of Novartis' Kisqali for HR+/HER2- early breast cancer, based on Phase 3 NATALEE trial data showing 25.1% lower risk of recurrence with Kisqali plus endocrine therapy vs. ET alone.

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.

Novartis receives CHMP positive opinion for Kisqali® to reduce HR+/HER2- early breast cancer recurrence risk, based on NATALEE trial data showing 25% reduction in recurrence with Kisqali + endocrine therapy vs. endocrine therapy alone.

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.

The committee recommended marketing authorisations for ten new medicines, including treatments for haemophilia, influenza, malignant ascites, tuberculosis diagnosis, hereditary transthyretin-mediated amyloidosis, and opioid dependence. Six existing medicines received extensions of indication, while two applications were withdrawn. The CHMP confirmed refusals for conditional marketing authorisations for masitinib and non-renewal for Translarna. Updates to COVID-19 vaccines were also approved. Outi Mäki-Ikola was elected as the new CHMP vice-chair.