Novartis has received the FDA's approval for Kisqali in combination with an aromatase inhibitor to treat patients with HR+/HER2- early breast cancer.
Kisqali — or ribociclb — is suitable for those with stage II and III breast cancer who are at high risk of recurring disease.
This includes patients with node-negative (N0) disease.
The approval stems from the Phase III NATALEE trial, which reduced the risk of disease recurrence in patients by 25.1% when they were given Kisqali plus endocrine therapy (ET) compared to ET alone.
This effect was seen across all patient subgroups in the study.
Kisqali is an oral therapeutic which should be taken once daily for three weeks with a week break, for three years.
Analysis further highlights Kisqali's efficacy
Further analysis on the trial's findings, which were presented at the European Society for Medical Oncology's 2024 congress, further reinforces the data that was presented to the FDA.
Results indicated that there was a deepening benefit to taking Kisqali with supplemental ET, reducing the risk of recurrence in patients by 28.5%.
Dennis J. Slamon, Director of Clinical/Translational Research, UCLA Jonsson Comprehensive Cancer Center and Chairman of the Board of Translational Research In Oncology (TRIO) and NATALEE trial lead investigator. “The FDA approval of Kisqali for this early breast cancer population, including those with N0 disease, is a pivotal moment in improving our approach to care,”
“Today’s 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.”
Valarie Worthy, Co-Founder & Vice President of Community Outreach and Engagement, Touch, The Black Breast Cancer Alliance, added: "Breast cancer treatment can take a toll on your physical and mental health, and you may worry about the risk of your cancer coming back. This risk is different for everyone, depending on many factors, but should not be underestimated,"
"The FDA approval of Kisqali for more people with breast cancer is welcome news and empowers people diagnosed with early breast cancer with a new option to help manage and control their risk of cancer coming back.”