Novartis Reports the US FDA’s Approval of Kisqali (Ribociclib) for the Treatment of HR+/HER2- Early Breast Cancer
Shots:
- The US FDA has granted approval to Kisqali in addition to aromatase inhibitor (AI) as an adj. treatment of HR+/HER2- stage II & III early breast cancer (EBC) patients at high risk of recurrence [includes node -ve (N0) disease]
- The approval was supported by P-III (NATALEE) study (conducted in partnership with TRIO) assessing Kisqali + ET vs ET alone as an adj. treatment of stage II & III HR+/HER2- EBC
- Study demonstrated reduced risk of recurrence by 25.1% with similar iDFS results across all the treatment groups. Updated data (4yrs. post-hoc analysis), highlighted at ESMO 2024, showed reduced risk of recurrence by 28.5%; further evaluation continues for long-term results (such as OS)
Ref: Novartis | Image: Novartis
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
