Novartis Expands Kisqali Use to Early-Stage Breast Cancer, Doubling Patient Pool

The FDA has given the green light for the expanded use of Novartis' Kisqali, now including patients with earlier stages of breast cancer. This approval specifically targets individuals with stage II or III early breast cancer who are HR-positive/HER2-negative and at a heightened risk of recurrence. According to Novartis, this expanded indication nearly doubles the number of patients eligible for treatment, encompassing those whose cancers have not yet affected the lymph nodes. This new approval covers the use of Kisqali in conjunction with an aromatase inhibitor for adjuvant therapy in breast cancer patients.

Victor Bultó, U.S. president of Novartis, celebrated the approval, stating that it redefines treatment options for breast cancer patients who remain at a persistent risk of recurrence. The majority of breast cancer cases—about 90%, as per Novartis—are identified early, usually in stages I to III, and are treated with the goal of curing the disease. Despite this early intervention, many patients, particularly those who are HR-positive/HER2-negative, face the threat of the disease returning in a more aggressive form.

Bultó emphasized that the approval builds on Kisqali’s established success in metastatic settings and now supports a broader range of individuals in their quest to remain cancer-free following an early-stage diagnosis. The expanded use of Kisqali is supported by findings from the Phase III NATALEE trial. In March 2023, Novartis announced topline data from this study, highlighting a significant improvement in disease-free survival compared to standard adjuvant endocrine therapy alone. Although specific data were not initially disclosed, an independent data monitoring committee had recommended ending the study early due to its positive results.

On the eve of the FDA's approval, Novartis shared updated data from the NATALEE trial, revealing that the treatment regimen "shows a deepening benefit" after three years. Long-term follow-up indicated that Kisqali combined with endocrine therapy reduced the risk of recurrence by 28.5% compared to endocrine therapy alone. The data also demonstrated significant distant disease-free survival benefits in favor of Kisqali, with overall survival showing a tendency toward improvement.

Kisqali is designed to be taken orally and works as a small-molecule inhibitor of the CDK4 and CDK6 kinases. These kinases are crucial components of signaling pathways that drive cell cycle progression and proliferation. According to its label, Kisqali’s mechanism of action helps in reducing tumor volume and blocking further tumor growth. The FDA first approved Kisqali in March 2017 for HR-positive/HER2-negative metastatic breast cancer, with its indication expanded in July 2018 to include advanced disease.

This latest FDA approval marks another milestone for Novartis in its mission to provide comprehensive cancer care. The inclusion of earlier-stage breast cancer patients who are at risk of recurrence showcases the evolving landscape of cancer treatment, offering hope and potentially improved outcomes for a broader patient population.