Novartis’ Kisqali (Ribociclib) Gains the CHMP’s Positive Opinion as an Adjuvant Treatment of HR+/HER2- Early Breast Cancer (EBC)
Shots:
- The CHMP has granted positive opinion to Kisqali as an adj. for treating HR+/HER2- EBC in patients with high risk of recurrence, incl. node -ve disease, with the decision expected in 2mos.
- The opinion was supported by the P-III (NATALEE) study assessing the safety & efficacy of Kisqali + ET vs ET alone as an adj. treatment of HR+/HER2- EBC (stage II & III) in adults (n=5,101) in 20 regions
- Study depicted a reduction in the risk of cancer recurrence by 25.1% and similar invasive disease-free survival (iDFS) benefit in pre-specified subgroups. Updated data, featured at ESMO 2024, showed Kisqali's sustained benefit in lowering recurrence risk, with a stronger iDFS benefit beyond the 3yrs. treatment period
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.
