Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its Kisqali (ribociclib), a cyclin-dependent kinase (CDK) 4/6 inhibitor. The drug is now approved for use as initial endocrine therapy in premenopausal or perimenopausal female patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, locally advanced or metastatic breast cancer, in combination with an aromatase inhibitor and a luteinizing hormone-releasing hormone (LHRH) agonist. Kisqali is the only CDK4/6 inhibitor approved for this indication in China.
Global Approval and Clinical Data
Ribociclib was first approved in the US in March 2017 for first-line treatment of postmenopausal women with HR+/HER2- advanced or metastatic breast cancer, followed by EU approval five months later. Novartis filed for approval in China in October 2021. The drug is currently available in 95 countries worldwide and is the only CDK4/6 inhibitor to demonstrate clear, statistically significant overall survival benefits in HR+/HER2- locally advanced or metastatic breast cancer.
MONALEESA Study Results
The MONALEESA global study includes three trials filed by Novartis. The MONALEESA-7 study results showed that ribociclib combined with endocrine therapy produced statistically significant benefits in progression-free survival (PFS) and overall survival (OS) compared to endocrine therapy alone in premenopausal patients with HR+/HER2- advanced breast cancer. The NMPA approval is based on a China-specific study, which demonstrated PFS benefits and good safety characteristics for ribociclib compared to placebo, regardless of menopausal status. The overall safety profile was consistent with known adverse reactions and aligned with the global MONALEESA study results.-Fineline Info & Tech
