BASEL (dpa-AFX) - Novartis (NVS) said that the European Commission has approved Kisqali (ribociclib) in combination with an aromatase inhibitor 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.
The approval was 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% reduction in risk of disease recurrence with adjuvant Kisqali plus endocrine therapy (ET) compared to endocrine therapy alone. The invasive disease-free survival (iDFS) benefit was consistently observed across all patient subgroups.
The European Commission approval follows the recent U.S. Food and Drug Administration (FDA) approval of Kisqali for early breast cancer 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).
Regulatory review of Kisqali in early breast cancer is ongoing worldwide, the company said.
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