Novartis’ Kisqali receives FDA approval to reduce the risk of breast cancer recurrence
The FDA approved Novartis’ Kisqali in combination with endocrine therapy (hormone therapy) based on the results from the pivotal Phase 3 NATALEE trial. The results showed a 25.1% reduction in the risk of recurrence in people with HR+/HER2- stage two and three breast cancer, who had also been treated with endocrine therapy compared to people who had only received endocrine therapy.
NATALEE is a global Phase 3 multi-center, randomized, open-label trial evaluating the safety and efficacy of Kisqali. For three years, trial participants either received Kisqali in combination with endocrine therapy (hormone therapy) or only received endocrine therapy. More than 5.000 adult patients with HR+/HER2- early breast cancer from 20 countries participated in the trial.
"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," said Dennis J. Slamon, Director of Clinical/Translational Research at UCLA Jonsson Comprehensive Cancer Center and Chairman of the Board of Translational Research In Oncology (TRIO) and lead investigator of the NATALEE trial, in a press statement.
"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."
Kisqali belongs to a class of drugs called selective cyclin-dependent kinase inhibitors, which can slow cancer progression by blocking the two proteins cyclin-dependent kinase 4 and 6 (CDK4/6). When over-activated, CDK4/6 make cancer cells grow out of control. By targeting and inhibiting CDK4/6, Kisqali prevents cancer cells from replicating uncontrollably.
Kisqali was first approved by the FDA in 2017 for the treatment of metastatic breast cancer and is now approved in 99 countries worldwide for that same indication. This most recent approval extends the use of Kisqali to patients with HR+/HER2- early breast cancer, the most common form of the disease, accounting for 60-70% of all breast cancer cases. The drug will be available for people with a stage two or three diagnosis, which means that the cancer has not yet spread to the lymph nodes and beyond the breast.
While 90% of breast cancer cases in the U.S. are diagnosed and treated early, people with stage two and three HR+/HER2- early breast cancer are at risk of the cancer returning, even if their lymph nodes were not affected. Although most tumors return within the first years after treatment, recurrence remains a lifelong concern.
"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," said Valarie Worthy, Co-Founder & Vice President of Community Outreach and Engagement at Touch, The Black Breast Cancer Alliance, in a press statement.
"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."
