
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National Comprehensive Cancer Network® (NCCN®) recognizes ribociclib (KISQALI®) as a Category 1 Preferred CDK4/6 inhibitor in combination with an AI for appropriate patients with HR+/HER2- eBC—the only one to receive this designation for both high-risk node-negative and any node-positive disease.1
High-risk node-negative disease is defined as either tumor size >5 cm, or if tumor size 2-5 cm, either grade 2 (with high genomic risk or Ki-67 ≥20%), or grade 3.1,2
NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.1
NATALEE was a randomized, multicenter, open-label, phase III study of KISQALI + letrozole or anastrozole (n=2549) vs letrozole or anastrozole (n=2552) for the adjuvant treatment of men and women with stage II/III HR+/HER2- eBC. At a median follow-up of 33.3 months, with 509 iDFS (primary end point) events in the study (226 [8.9%] in the KISQALI arm and 283 [11.1%] in the NSAI-alone arm), iDFS at the 3-year landmark was 90.7% for KISQALI + NSAI vs 87.6% for NSAI alone (absolute difference 3.1%); there was a 25.1% relative reduction in the risk of an iDFS event; HR=0.749 (95% CI: 0.628-0.892).1,2
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