The recent regulatory approval and guideline updates now support the use of ribociclib in high-risk node-negative patients based on outcomes of the NATALEE trial

Ribociclib is the first CDK4/6 inhibitor to be approved for use in high-risk node-negative eBC patients, and guidelines are starting to recommend it.^1-4

NCCN Category¹ Update



National Comprehensive Cancer Network (NCCN) recognizes ribociclib (KISQALI®) as a category 1 preferred CDK4/6 inhibitor in combination with an Al 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.²

 

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Exciting NCCN Guidelines Update for KISQALI® eBC

NCCN updated its guidelines to make KISQALI® a category 1 preferred CDK4/6 inhibitor in combination with AI consistent with its labeled indication, including N0 high-risk node positive HR+/HER2- eBC patients.²
NCCN Language: For those with any lymph node involvement (excluding microscopic nodal involvement), or if no nodal involvement either tumor size >5 cm, or if tumor size 2-5 cm, either grade 2 (and high genomic risk or Ki-67 ≥20%), or grade 3, three years of ribociclib with aromatase inhibitor may be considered (category 1 preferred).²

 

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*Additional conditions may apply. †Category 1: Based upon high-level evidence. There is a uniform NCCN consensus that the intervention is appropriate.
‡A single rating is provided for the entire ITT population.
ASCO, American Society of Clinical Oncology; BC, breast cancer; CDK4, cyclin-dependent kinase 4; eBC, early breast cancer; ESMO, European Society for Medical Oncology; HER2, human epidermal growth factor receptor 2; HR, hormone receptor; ITT, intent to treat; MCBS, magnitude of clinical benefit scale; NCCN, National Comprehensive Cancer Network.