This month, the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for breast cancer were updated to recommend ribociclib (Kisqali®) as a Category 1 preferred CDK4/6 inhibitor (CDK4/6i) adjuvant therapy for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) in combination with an aromatase inhibitor (AI)1. Ribociclib (Kisqali) is the only CDK4/6i recommended for both all node-positive disease as well as for patients with no nodal involvement with high-risk disease characteristics, such as tumor size >5 cm, or for tumors sized 2-5 cm, either Grade 2 with high genomic risk/Ki-67 ≥20% or Grade 31.

“These evidence-based guidelines are helpful to clinicians when determining optimal treatment options for patients,” said Shreeram Aradhye, M.D., President, Development and Chief Medical Officer, Novartis. “Importantly, the NCCN Guideline recommendation of ribociclib in this broad population reaffirms the importance of offering eligible patients with early breast cancer, including those with limited nodal involvement and high-risk N0 disease, a CDK4/6i treatment like ribociclib in addition to endocrine therapy to reduce their risk of recurrence.”

A Category 1 recommendation by the NCCN Guidelines indicates high levels of clinical evidence and uniform consensus among NCCN on ribociclib (Kisqali) as an appropriate treatment for these patients. This recommendation comes after the presentation of longer-term results from the Phase III NATALEE trial at the European Society for Medical Oncology (ESMO) Congress 2024, which showed a deepening efficacy benefit beyond the Kisqali treatment duration in a broad population of patients, including those with node-negative disease; as well as the recent FDA approval and CHMP positive opinion for Kisqali in the EBC indication2.

The updated guidelines, consistent with the FDA indication per the NATALEE trial, approximately double the number of patients that could benefit from treatment with a CDK4/6i in the adjuvant setting3.

NCCN Guidelines also continue to recommend ribociclib (Kisqali) as the only Category 1 preferred CDK4/6i for first-line treatment of patients with HR+/HER2- metastatic breast cancer in combination with an AI; ribociclib (Kisqali) is also recommended as a Category 1 preferred regimen for first- and subsequent-line therapies** in HR+/HER2- MBC in combination with fulvestrant1.

To access NCCN Guidelines, visit www.nccn.org.

* Adjuvant treatment with Kisqali has only been studied in high-risk patients. 
** If CDK4/6 inhibitor was not previously used.

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.

 

Source: novartis.com

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