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Latest Novartis Kisqali NATALEE Analysis Reinforces 25% Reduction In Risk Of Recurrence Across Broad Population Of Patients With Early Breast Cancer; Supports Regulatory Submissions
Novartis AG Sponsored ADR +0.16%
Novartis AG Sponsored ADR NVS | 132.57 | +0.16% |
- With 5.6 months of additional follow-up and 78.3% of patients having completed Kisqali® (ribociclib) investigational treatment, the updated analysis shows sustained iDFS benefit and stability in secondary endpoints including overall survival (OS)1,2
- iDFS benefit remains consistent across key patient subgroups; among patients with stage II and stage III tumors, Kisqali lowered risk by 30% and 24.5%, respectively1,2
- Latest analysis continues to show a well-tolerated safety profile in line with previously reported results, and quality of life for Kisqali patients preserved vs. endocrine therapy (ET) alone1,2,3
- Risk of recurrence remains a short and long term concern; one in eight women treated with ET alone in NATALEE likely to experience invasive disease at 3 years1,2
- Kisqali is currently approved in the metastatic setting, where it has consistently demonstrated statistically significant OS benefit across three Phase III trials4-15;Novartis has filed NATALEE results with EMA and will submit these latest EBC data to the FDA by end of year
