If approved, patients in Europe with stage II or III HR+/HER2- early breast cancer (EBC) at high risk of recurrence, including those with node-negative disease, will be eligible for adjuvant treatment with Kisqali® (ribociclib) in combination with an aromatase inhibitor.
Recommendation is based on the Phase III NATALEE trial, where Kisqali added to endocrine therapy (ET) significantly reduced the risk of recurrence by 25% versus ET alone across a broad population of patients with HR+/HER2- early breast cancer.
People with stage II or III HR+/HER2- EBC face significant risk of recurrence – often as incurable metastatic disease – despite adjuvant ET and regardless of nodal involvement.
In September, Kisqali was approved by the FDA in this setting5; at ESMO 2024, an updated analysis from NATALEE was presented, showing a deepening invasive disease-free survival benefit.
Kisqali® (ribociclib) is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably.
Kisqali was approved as a treatment for early breast cancer by the U.S. Food and Drug Administration (FDA) in September 20245. Regulatory reviews for Kisqali as an EBC treatment are ongoing worldwide, including in the EU and China.
