The US Food and Drug Administration (FDA) has approved a label expansion for ’s Kisqali (ribociclib), allowing it to be used as an add-on therapy in early breast cancer patients. The therapy is approved as a combination treatment with an aromatase inhibitor for the adjuvant treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) stage II and III early breast cancer at high risk of recurrence, including those with node-negative (N0) disease. Kisqali is a cyclin-dependent kinase (CDK) 4 and 6 inhibitor.
The FDA first in postmenopausal HR+/HER2- advanced or metastatic breast cancer patients in 2017. The following year, the US regulatory agency expanded the Kisqali label to HR+/HER2- advanced or metastatic breast cancer irrespective of the patient’s menopausal status. The FDA also approved the therapy’s use in combination with fulvestrant as both first-line and second-line treatment in postmenopausal women with advanced breast cancer.
Kisqali is a high-grossing cancer therapy for Novartis having raked in and has generated $1.34bn in sales in the first half of 2024, according to company financials. GlobalData expects the therapy’s global sales to increase to more than $8bn by 2030.
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