New EC approval for Novartis’ Kisqali

Novartis (NOVN: VX) announced today that the European Commission (EC) has approved 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) at high risk of recurrence.

According to the Swiss pharma giant, the approval is based on results from the pivotal Phase III NATALEE trial, which included a broad patient population with HR+/HER2- stage II and III EBC, including those with node-negative disease. The trial showed a significant and clinically-meaningful 25.1% (HR=0.749; 95% CI: 0.628, 0.892; P=0.0006) reduction in risk of disease recurrence with adjuvant Kisqali plus endocrine therapy (ET) compared to ET alone. The invasive disease-free survival (iDFS) benefit was consistently observed across all patient subgroups, said Novartis.

Kisqali, first approved by the US Food and Drug Administration in 2017 for metastatic breast cancer, is already an important growth driver for Novartis, generating global third-quarter 2024 revenues of $787 million, up 40% year-on-year.