Novartis’ Kisqali (ribociclib) has been approved by the US Food and Drug Administration (FDA) as part of a combination treatment for early breast cancer.
The CDK4/6 inhibitor has been authorised in combination with an aromatase inhibitor for the adjuvant treatment of patients with hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative stage 2 and 3 early breast cancer that is at high risk of recurrence, including those with node-negative disease.
The approval is supported by positive results from the late-stage NATALEE trial, in which adjuvant Kisqali plus endocrine therapy reduced the risk of recurrence by 25.1% compared to endocrine therapy alone in a broad population of HR-positive/HER2-negative stage 2 and 3 early breast cancer patients.
Results from an updated analysis of the trial, presented at this year’s European Society for Medical Oncology Congress, also showed a deepening benefit beyond the three-year treatment period, with the Kisqali combination lowering the risk of recurrence by 28.5% compared to endocrine therapy alone.
Despite approximately 90% of breast cancer cases in the US being diagnosed early and treated promptly with curative intent, patients with stage 2 and 3 HR-positive/HER2-negative early breast cancer remain at risk of their cancer coming back, in most cases as incurable metastatic disease.
Already approved for certain cases of advanced or metastatic breast cancer, Kisqali is designed to inhibit the CDK4/6 proteins which, when over-activated, can enable cancer cells to grow and divide too quickly.
Commenting on the drug’s latest authorisation, NATALEE trial lead investigator Dennis Slamon, UCLA Jonsson Comprehensive Cancer Center, said: “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.
“[This] 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 minimise their risk of cancer returning.”
Novartis outlined that regulatory reviews for Kisqali as an early breast cancer treatment are ongoing globally, including in the EU.