NCCN guidelines recognize Novartis’ ribociclib as preferred adjuvant treatment for stage 1 breast cancer – Healthcare News

The NCCN Oncology Clinical Practice Guidelines (NCCN Guidelines) for breast cancer were updated this month to recommend ribociclib (Kisqali) as the preferred category 1 adjuvant CDK4/6 inhibitor (CDK4/6i) therapy for to patients with breast cancer.

According to a press release, Ribociclib (Kisqali) is the only CDK4/6i recommended for both all node-positive disease and node-negative patients with high-risk disease features, such as tumor size >5 cm, or 2-5 cm tumors, either grade 2 with high genomic risk/Ki-67 ≥20% or grade 31.

“These evidence-based guidelines are helpful for clinicians in determining optimal treatment options for patients,” said Shreeram Aradhye, MD, president of development and chief medical officer at Novartis. “Importantly, the NCCN Guideline’s 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 treatment CDK4/6i such as ribociclib in addition to endocrine therapy to reduce their risk of recurrence.”

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

The updated guidelines, consistent with the FDA indication for the NATALEE trial, roughly double the number of patients who could benefit from treatment with a CDK4/6i in the adjuvant setting, he added.

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