The U.S. Food and Drug Administration (FDA) has approved Novartis’ Kisqali (CDK4/6 inhibitor ribociclib) for patients with early breast cancer (EBC) at high risk of recurrence, including those with node-negative (N0) disease. Kisqali is one of Novartis’ top selling cancer drugs, bringing in over $1B per year now. This new approval is estimated to add more than $3 billion to the drug’s annual peak sales.
The new approval not only approximately doubles the drug’s eligible treatment population—it also distinguishes Kisqali from competitor Lilly’s Verzenio by covering patients without cancer cells in their lymph nodes. Verzenio’s approval is limited to patients with nodal involvement.
Kiqali is already approved for metastatic HR+/HER2- breast cancer. It can now be also used in combination with an aromatase inhibitor, in the adjuvant treatment of HR-positive, HER2-negative stage II and III breast cancer at high risk of recurrence after surgery.
“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,” said Dennis J. Slamon, MD, PhD, director of clinical/translational research, UCLA Jonsson Comprehensive Cancer Center and NATALEE trial lead investigator, in a press release.
This week’s approval is based on results from the pivotal Phase III NATALEE trial, which showed a significant and clinically meaningful 25.1% reduction in risk of disease recurrence in a broad population of patients with HR+/HER2- stage II and III EBC treated with adjuvant Kisqali plus endocrine therapy (ET) compared to ET alone, including those with high-risk N0 disease. The invasive disease-free survival benefit was consistently observed across all patient subgroups.
An updated analysis from the NATALEE trial recently presented at the European Society for Medical Oncology (ESMO) Congress 2024 reinforces the data analyzed by the FDA. Results showed a deepening benefit beyond the three-year treatment period and reduced the risk of recurrence by 28.5%, compared to ET alone, in patients with stage II and III HR+/HER2- EBC7. Novartis will continue evaluating NATALEE patients for longer-term outcomes, including overall survival.
Approximately 90% of breast cancer cases in the US are diagnosed early (stages I-III) and treated promptly with curative intent—sometimes with adjuvant ET21,22. In spite of this, people with stage II and III HR+/HER2- EBC remain at risk of cancer coming back—in most cases, as an incurable metastatic disease. Recurrence remains a lifelong concern, though most tumors return within the first years, even in cases with no lymph node involvement. Despite ET, 10% of people with high-risk N0 disease may face recurrence within the first three years after diagnosis.
“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 and VP of community outreach and engagement, touch, The Black Breast Cancer Alliance.
“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.”
