Novartis Submits New NDA in China for CDK4/6 Inhibitor Kisqali as Adjuvant Therapy in HR+/HER2- Early Breast Cancer

Dec 19, 2023 07:46 CST Updated 07:46

Novartis

Drug Development and Manufacturing

On December 19, the CDE website showed,NovartisCDK4/6 Inhibitor Ribociclib New Indication Marketing Application Accepted by NMPA. The indication for this submission is speculated to be: RibociclibCombination Endocrine Therapy (ET) for Adjuvant Treatment in HR+/HER2- Early Breast Cancer Patients.

In January this year, Ribociclib was approved for marketing in China for the first time, with the indication ofIn combination with aromatase inhibitors (AI) as first-line treatment for premenopausal or perimenopausal HR+/HER2- advanced breast cancer; five months later, the indication for ribociclib was expanded to includePostmenopausalHR+/HER2-Locally advanced or metastatic breast cancer,Combination of AI and medication as the initial endocrine therapy for female patients results inRibociclib becomes the first and currently the only CDK4/6 inhibitor in China to cover premenopausal/perimenopausal and postmenopausal populations in the first-line treatment of advanced breast cancer.6 inhibitor.

Recently, Novartis announced Riboocil.Combined Endocrine TherapyLatest Data from the Phase III NATALEE Study on Adjuvant Treatment for HR+/HER2- Early Breast Cancer Patients. The results show,Compared with ET alone, the risk of disease recurrence in patients receiving Ribociclib combined with ET was reduced by 25.1% (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), so the overall survival (OS) results will continue to evolve over the long term.

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

Welcome to forward, share, and reasonably cite. When citing, please clearly indicate the source of the article.For reprint, please leave a message or send a message to the WeChat Official Account backend, and indicate the name and ID of the official account.

Disclaimer: The information in this WeChat article is for general reference only and should not be directly used as decision-making content. PharmaCube assumes no responsibility for any loss incurred by any party due to the use of the content herein.