Swiss pharmaceutical company Novartis (NYSE: NVS) has announced that it has received marketing approval from the European Commission (EC) for its CDK4/6 inhibitor Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) who are at high risk of recurrence.
Phase III NATALEE Study Results Inform Regulatory Decision
The regulatory decision is supported by the results from the Phase III NATALEE study, which enrolled a diverse patient population with HR+/HER2- stage II and III EBC. This study provides a robust evidence base for the efficacy and safety of Kisqali in this patient population, according to Novartis.
Global Approvals and Unique Positioning of Kisqali
Kisqali was first approved in the US in March 2017 for the first-line treatment of postmenopausal women with HR+, HER2- advanced or metastatic breast cancer when combined with AI. Subsequent approvals followed in the European Union (EU) and China. Registered in over 100 countries worldwide for the treatment of EBC, Kisqali stands out as the only CDK4/6 inhibitor globally proven to offer a clear and statistically significant total survival benefit in combination with various endocrine drugs in HR+/HER2 locally advanced or metastatic breast cancer.-Fineline Info & Tech
