Novartis Kisqali gets European Commission nod in patients with HR+/HER2-early breast cancer at high risk of recurrence

In addition, Michael Untch, M.D., Professor and Head of the Clinic for Gynecology and Obstetrics, and Director of the Interdisciplinary Breast Cancer Center at Helios Klinikum Berlin-Buch, noted“, Adding a new treatment option to the HR+/HER2- early breast cancer armamentarium is encouraging news for both physicians and their patients – including patients with node-negative disease and additional risk factors. Ribociclib may now help many patients who are at risk of their cancer returning.”

Breast cancer is the most commonly diagnosed cancer in Europe, with approximately 70% of cases diagnosed in the early stages of the disease. Despite current treatment options, people with stage II and III HR+/HER2- EBC remain at risk of experiencing a return of their cancer in the long term, often as incurable advanced disease.

"Breast cancer recurrence can be a lifelong concern for those living with the disease. Patients deserve access to treatment options that help minimize the risk of their cancer coming back and put their mind at ease,” said Iris Zemzoum, M.D., President, Europe, Novartis. “We are proud of this approval, which will help to address a key unmet need and improve health outcomes for a broader population of patients in Europe.”

This news follows the recent U.S. Food and Drug Administration (FDA) approval of Kisqali for EBC patients and recommendation as a Category 1 preferred breast cancer adjuvant treatment by the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®*). Kisqali has also achieved the highest score (A) on the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) for EBC12.

Regulatory review of Kisqali in EBC is ongoing worldwide. Following recent data announcements at ESMO 20246, Novartis will continue to evaluate NATALEE patients for longer-term outcomes, including overall survival.