FDA Approves Novartis' Kisqali Combo for Early Breast Cancer

The U.S. Food and Drug Administration (FDA) has approved Novartis' medication, Kisqali (ribociclib), for use in combination therapy aimed at treating early-stage breast cancer. Specifically, Kisqali has been sanctioned for adjuvant treatment in patients diagnosed with hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative stage 2 and stage 3 breast cancer, particularly those at high risk of recurrence. This includes patients with node-negative disease.

The FDA's decision builds on positive findings from the late-stage NATALEE clinical trial. The trial demonstrated that combining Kisqali with endocrine therapy decreased the risk of cancer recurrence by 25.1% in a diverse group of patients with HR-positive/HER2-negative stage 2 and 3 early breast cancer compared to those receiving endocrine therapy alone.

Further analysis of the NATALEE trial data, presented at this year’s European Society for Medical Oncology Congress, indicated that the benefits of Kisqali extend beyond the initial three-year treatment period. The combination therapy reduced the risk of recurrence by 28.5% when compared to endocrine therapy alone, showing a sustained improvement in patient outcomes.

In the United States, roughly 90% of breast cancer cases are detected at an early stage and are treated with curative intent. However, patients with stage 2 and 3 HR-positive/HER2-negative early breast cancer still face a significant risk of their disease returning, often as metastatic cancer, which is generally incurable.

Kisqali is already approved for use in certain scenarios involving advanced or metastatic breast cancer. The drug functions by inhibiting CDK4/6 proteins, which can cause cancer cells to multiply too rapidly when they are overly active.

The lead investigator of the NATALEE trial, Dennis Slamon from the UCLA Jonsson Comprehensive Cancer Center, emphasized the significance of the FDA's latest approval. He noted that this decision marks a critical advancement in treating HR-positive/HER2-negative early breast cancer, including cases with node-negative disease. “The FDA approval of Kisqali for this early breast cancer population, including those with node-negative disease, is a pivotal moment in improving our approach to care," Slamon stated. "This approval allows us to offer treatment with a CDK4/6 inhibitor to a significantly broader group of people as a powerful tool that, combined with endocrine therapy, can help further minimize their risk of cancer returning.”

Novartis also mentioned that regulatory assessments for the use of Kisqali as a treatment for early breast cancer are ongoing in various regions worldwide, including the European Union.