NCCN Guidelines® Name Novartis' Kisqali® as Preferred Category 1 Breast Cancer Adjuvant Therapy

In October 2024, the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for breast cancer have been revised to endorse ribociclib (Kisqali®) as a Category 1 preferred CDK4/6 inhibitor (CDK4/6i) adjuvant treatment. This recommendation is for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) when used alongside an aromatase inhibitor (AI). Ribociclib remains the sole CDK4/6i suggested for patients with all node-positive disease and also for high-risk node-negative patients with specific tumor characteristics.

Dr. Shreeram Aradhye, President of Development and Chief Medical Officer at Novartis, emphasized that these guidelines aid clinicians in selecting the best treatment strategies for their patients. He highlighted that this extensive recommendation for ribociclib underscores the importance of providing eligible early breast cancer patients, including those with limited nodal involvement and high-risk features, with CDK4/6i therapy in addition to endocrine therapy to lower recurrence risks.

The NCCN's Category 1 recommendation reflects robust clinical evidence and a broad consensus on ribociclib's suitability for these patients. This update follows the presentation of extended findings from the Phase III NATALEE trial at the European Society for Medical Oncology (ESMO) Congress 2024. The trial demonstrated sustained efficacy benefits surpassing the treatment duration of Kisqali in a wide range of patients, including those with node-negative conditions. Additionally, the positive opinion from the CHMP and recent FDA approval for Kisqali in the EBC setting further support this recommendation.

The updated guidelines are consistent with the FDA's indication based on the NATALEE trial results, potentially doubling the number of patients who might gain from a CDK4/6i therapy in the adjuvant context. Ribociclib continues to be recommended as the only Category 1 preferred CDK4/6i for first-line therapy of patients with HR+/HER2- metastatic breast cancer in combination with an AI. Additionally, ribociclib is endorsed for first and subsequent-line treatments in HR+/HER2- metastatic breast cancer when used with fulvestrant if a CDK4/6 inhibitor was not previously used.

Ribociclib (Kisqali) is a selective cyclin-dependent kinase inhibitor that hinders the activity of CDK4 and CDK6, proteins integral to cancer cell proliferation. By targeting these proteins, ribociclib can prevent cancer cells from replicating uncontrollably. Besides its recent approvals for early breast cancer patients in the United States and Europe, ribociclib is undergoing regulatory reviews globally. It has received approval for treating metastatic breast cancer in 99 countries, sanctioned by authorities including the US FDA and the European Commission.

In the US, ribociclib is approved for treating adults with HR+/HER2- advanced or metastatic breast cancer. It is used in combination with an AI as initial endocrine therapy or with fulvestrant as initial endocrine therapy or after disease progression on endocrine therapy in post-menopausal women or men. Ribociclib has shown a significant overall survival benefit in three Phase III clinical trials for metastatic breast cancer.

Ribociclib was developed by Novartis in collaboration with Astex Pharmaceuticals. With a rich history spanning over 35 years, Novartis has been at the forefront of advancing treatment for breast cancer, working closely with the global medical community to innovate and improve clinical practices. Novartis continues to lead the industry with an extensive portfolio and pipeline of therapies targeting HR+/HER2- breast cancer, the most prevalent form of the disease.

Kisqali® (ribociclib) is specifically indicated for treating adults with HR+/HER2- breast cancer in several settings: combined with an AI for high-risk stage II and III early breast cancer, and for advanced or metastatic breast cancer that has worsened or spread, used with an AI as initial endocrine-based therapy or with fulvestrant. It is not established whether Kisqali is safe or effective in children.