Novartis Submits New Drug Application in China for Ribociclib as Adjuvant Therapy in HR+/HER2- Early Breast Cancer

On December 19, the CDE website showed that the new indication application for CDK4/6 inhibitor Ribociclib was accepted by the NMPA. It is speculated that the indication applied for this time is: Ribociclib in combination with endocrine therapy (ET) for adjuvant treatment of HR+/HER2- early breast cancer patients.

In January this year, Ribociclib was approved for marketing in China for the first time, indicated for use in combination with aromatase inhibitors (AI) as a first-line treatment for premenopausal or perimenopausal HR+/HER2- advanced breast cancer; subsequently in May, the indication for Ribociclib was expanded to include postmenopausal HR+/HER2- locally advanced or metastatic breast cancer, used in combination with AI as the initial endocrine therapy for female patients. This makes Ribociclib the first and currently the only CDK4/6 inhibitor in China that covers premenopausal/perimenopausal and postmenopausal populations in the field of first-line treatment for advanced breast cancer.

Recently, Novartis announced the latest data from the Phase III NATALEE study on ribociclib combined with endocrine therapy (ET) for adjuvant treatment of HR+/HER2- early breast cancer patients. The results showed that, compared to ET alone, the risk of disease recurrence was reduced by 25.1% in patients receiving ribociclib plus ET (HR=0.749; 95% CI: 0.628, 0.892; p=0.0006).

Ribociclib also showed consistent data across all secondary efficacy endpoints, including distant disease-free survival (DDFS, with a 25.1% reduction in risk) and recurrence-free survival (RFS, with a 27.3% reduction in risk). The event rates in both treatment groups were less than 4% (3.3% in the ribociclib combination therapy group and 3.4% in the ET-only group), indicating that overall survival (OS) results will continue to evolve over the long term.

The safety of 400mg dose of Ribociclib is consistent with previously reported results, with generally low-grade adverse events (AEs) except for laboratory abnormalities. Notably concerning AEs (Grade 3 or higher) include neutropenia (44.3%), liver-related AEs (e.g., elevated transaminases) (8.6%), and QT interval prolongation (1.0%). No new safety signals were identified.

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