Novartis Kisqali Receives European Commission Approval for HR+/HER2- Early Breast Cancer at High Risk of Recurrence
Novartis recently announced that the European Commission (EC) has approved Kisqali® (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of HR+ HER2- early breast cancer (EBC) patients.
This approval is a significant milestone for the early breast cancer community and is based on the promising results from the Phase III NATALEE trial.
The trial demonstrated that Kisqali plus adjuvant endocrine therapy (ET) significantly reduced the risk of disease recurrence by 25.1% (HR=0.749; P=0.0006) in patients with stage II and III HR+/HER2- EBC, with benefits consistently observed across all subgroups, including those with node-negative disease.
This broad indication will now make nearly twice as many EBC patients in Europe eligible for Kisqali, offering them a critical option to help reduce the risk of recurrence.
“Despite treatment with endocrine therapy, over one-third of patients with stage II and III HR+/HER2- EBC still experience recurrence, often leading to incurable advanced disease,” – Michael Gnant, Professor of Surgery at the Medical University of Vienna.
“This approval offers a new, impactful treatment option to reduce the risk of recurrence in a broader patient population.”
The approval follows the U.S. FDA’s recent approval of Kisqali for EBC and its recommendation as a Category 1 preferred adjuvant treatment by the National Comprehensive Cancer Network (NCCN) Guidelines. Furthermore, Kisqali received the highest clinical benefit score (A) from the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) for EBC.
Novartis continues to evaluate the long-term outcomes of Kisqali treatment in ongoing trials and is committed to improving health outcomes for patients worldwide. Breast cancer remains the most commonly diagnosed cancer in Europe, and this approval brings much-needed hope to those at high risk of recurrence.
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