European Commission Approves Novartis' Kisqali® for High-Risk HR+/HER2- Early Breast Cancer

Novartis disclosed that the European Commission (EC) has granted approval for Kisqali® (ribociclib) to be used in conjunction with an aromatase inhibitor (AI) as an adjuvant therapy for patients suffering from hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) who are at a heightened risk of recurrence.

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The endorsement is founded on findings from the crucial Phase III NATALEE trial, featuring a diverse cohort of patients with HR+/HER2- stage II and III early breast cancer (EBC), including those without lymph node involvement. The study demonstrated a substantial and clinically relevant 25.1% (HR=0.749; 95% CI: 0.628, 0.892; P=0.0006) decrease in the likelihood of disease recurrence when adjuvant Kisqali was combined with endocrine therapy (ET) as opposed to ET alone. The improvement in invasive disease-free survival (iDFS) was consistently observed across various patient subgroups.

“Many patients diagnosed with stage II or III HR+/HER2- early breast cancer face a significant risk of recurrence despite undergoing endocrine therapy for many years,” stated Michael Gnant, M.D., FACS, FEBS, a Surgery Professor at the Medical University of Vienna, Austria, and President of the Austrian Breast and Colorectal Study Group. “This approval symbolizes a significant advancement for the early breast cancer community in Europe, providing physicians with an additional strategy to help minimize recurrence risk in a wider patient group.”

Furthermore, Michael Untch, M.D., Professor and Director of the Clinic for Gynecology and Obstetrics, as well as the Interdisciplinary Breast Cancer Center at Helios Klinikum Berlin-Buch, remarked: “The inclusion of a new treatment option in the HR+/HER2- early breast cancer arsenal is uplifting news for both clinicians and their patients, particularly those with node-negative disease and other risk factors. Ribociclib may now provide assistance to many patients at risk for cancer recurrence.”

Breast cancer remains the most prevalent cancer type in Europe, with around 70% of cases identified in the early stages. Despite existing treatment modalities, individuals with stage II and III HR+/HER2- EBC continue to face the danger of cancer recurrence over the long term, frequently advancing to incurable stages.

“Recurrence of breast cancer is a persistent worry for patients dealing with the disease. They deserve access to therapies that can help reduce the likelihood of recurrence and offer peace of mind,” expressed Iris Zemzoum, M.D., President for Europe at Novartis. “We take pride in this approval, aiming to meet a crucial unmet need and enhance health outcomes for a larger patient demographic in Europe.”

This development follows the recent approval of Kisqali by the U.S. Food and Drug Administration (FDA) for patients with EBC, as well as its designation as a Category 1 preferred adjuvant treatment for breast cancer by the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®*). Kisqali has also received the top rating (A) on the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) for EBC.

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According to the data provided by the Synapse Database, As of December 4, 2024, there are 148 investigational drugs for the CDK4 x CDK6 target, including 278 indications, 150 R&D institutions involved, with related clinical trials reaching 1123, and as many as 4434 patents.

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.