NEW YORK – The US Food and Drug Administration on Tuesday approved Novartis' CDK4/6 inhibitor Kisqali (ribociclib) in combination with an aromatase inhibitor as an adjuvant treatment for hormone receptor (HR)-positive, HER2-negative stage II and III early breast cancer at high risk of recurrence.
The approval was based on results from the pivotal Phase III NATALEE trial, in which the Kisqali combination showed a 25 percent reduction in invasive disease-free survival across all patient subgroups, including those with node-positive and node-negative disease. In updated data from the NATALEE trial reported this week at the European Society for Medical Oncology Congress in Barcelona, Spain, the four-year invasive disease-free survival rate was 88.5 percent on Kisqali plus an aromatase inhibitor compared to 83.6 percent with an aromatase inhibitor alone.
Kisqali is also approved in the US as a treatment for HR-positive, HER2-negative advanced or metastatic breast cancer in combination with endocrine therapy in the first-line setting and in combination with estrogen receptor antagonist fulvestrant in the first-line or after disease progression on endocrine therapy.
"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," Dennis Slamon, director of clinical/translational research at UCLA Jonsson Comprehensive Cancer Center and NATALEE trial lead investigator, said in a statement.
Last year, the FDA approved Eli Lilly's CDK4/6 inhibitor Verzenio (abemaciclib) in a similar indication, as an adjuvant treatment for patients with HR-positive HER2-negative early-stage breast cancer that has spread to the lymph nodes.