Novartis (NYSE: NVS), the Swiss pharmaceutical giant, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion recommending the approval of Kisqali (ribociclib), a CDK4/6 inhibitor, for the adjuvant treatment of adults with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) who are at high risk of disease recurrence, including patients with node-negative disease.
Kisqali, which has already gained global approvals for the treatment of HR+/HER2- advanced or metastatic breast cancer, received US approval for the treatment of early breast cancer in September 2024. The indication is currently under review in various regions worldwide, including the EU and China.
The positive CHMP decision is supported by substantial data from the Phase III NATALEE trial. The study demonstrated that Kisqali in combination with endocrine therapy (ET) significantly reduced the risk of cancer recurrence by 25.1% compared to ET alone in patients with stage II and III HR+/HER2- EBC (HR=0.749; 95% CI: 0.628, 0.892; P=0.0006). The trial also showed a consistent, clinically meaningful invasive disease-free survival (iDFS) benefit across key pre-specified subgroups. An updated analysis revealed that the iDFS benefit persisted beyond the three-year Kisqali treatment period in all patient subgroups, including those with node-negative disease.
This positive opinion from the CHMP highlights Kisqali’s potential role in improving outcomes for patients with early breast cancer and underscores Novartis’s commitment to advancing targeted therapies for breast cancer treatment.- Flcube.com
