FDA Approves Novartis Kisqali to Reduce Recurrence Risk in Early HR+/HER2- Breast Cancer

Novartis has announced that the US Food and Drug Administration (FDA) has approved Kisqali® (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of individuals with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) stage II and III early breast cancer (EBC) who are at high risk of recurrence, including those with node-negative disease.

This FDA approval is supported by the results of the Phase III NATALEE trial, which demonstrated a 25.1% reduction in the risk of disease recurrence for patients receiving Kisqali alongside endocrine therapy (ET) compared to those receiving ET alone. The trial included a wide range of patients with HR+/HER2- stage II and III EBC, and the benefits were seen consistently across all subgroups, including those with node-negative disease.

Dr. Dennis J. Slamon, one of the lead investigators of the NATALEE trial, emphasized the significance of this approval. He highlighted that this development allows a broader group of early breast cancer patients access to a CDK4/6 inhibitor, which, when combined with endocrine therapy, can significantly reduce the risk of cancer recurrence.

Kisqali is administered as a once-daily oral dose of 400 mg for three weeks, followed by a week off treatment, in combination with an AI for a total treatment period of three years. The NATALEE trial also demonstrated that Kisqali's safety profile was well-tolerated, with discontinuations primarily due to asymptomatic laboratory findings. Key adverse events observed included neutropenia, liver-related issues, QT interval prolongation, and interstitial lung disease/pneumonitis.

An updated analysis from the NATALEE trial, presented at the European Society for Medical Oncology (ESMO) Congress 2024, reinforced these findings. The data showed a further reduction in the risk of recurrence, down by 28.5% compared to ET alone, indicating sustained benefits beyond the three-year treatment period.

Breast cancer, particularly HR+/HER2- stage II and III EBC, poses a substantial risk of recurrence, often returning as incurable metastatic disease. Despite adjuvant endocrine therapy, recurrence remains a concern, with significant numbers of patients experiencing a return of the cancer within the first few years post-diagnosis. This new approval of Kisqali aims to address this persistent risk.

Victor Bultó, President of Novartis US, remarked that this approval redefines treatment options for a broader population, building on Kisqali’s established efficacy in metastatic breast cancer. He emphasized the company’s ongoing commitment to transforming cancer care and supporting patients in reducing the risk of recurrence.

Valarie Worthy, Co-Founder & Vice President of Community Outreach and Engagement at Touch, The Black Breast Cancer Alliance, expressed optimism about the new approval, noting that it provides patients with new options to manage the risk of cancer returning.

Novartis is also committed to ensuring patient access to Kisqali through a dedicated support program that helps patients navigate treatment initiation, understand insurance coverage, and explore financial assistance options.

Kisqali, a selective cyclin-dependent kinase inhibitor, has already been approved for the treatment of metastatic breast cancer in 99 countries. It works by targeting and inhibiting the proteins CDK4 and CDK6, which are involved in cancer cell division and growth. Regulatory reviews for its use in early breast cancer are ongoing worldwide.

In summary, the FDA approval of Kisqali for HR+/HER2- stage II and III early breast cancer at high risk of recurrence marks a significant advancement in breast cancer treatment, offering a new therapeutic option that has shown considerable efficacy in reducing the risk of disease recurrence.