FDA Approves Kisqali for Early Breast Cancer Treatment

The US Food and Drug Administration (FDA) has approved an expanded use for Novartis’s Kisqali (ribociclib), now permitting its application as an additional therapy for early-stage breast cancer patients. This approval allows for Kisqali to be combined with an aromatase inhibitor as an adjuvant treatment for hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) stage II and III early breast cancer patients who are at a high risk of recurrence, which includes those with node-negative (N0) disease.

Kisqali functions as a cyclin-dependent kinase (CDK) 4 and 6 inhibitor. Initially, it received FDA approval in 2017 for use in combination with aromatase inhibitors in postmenopausal patients with HR+/HER2- advanced or metastatic breast cancer. The subsequent year, its label was expanded to include all HR+/HER2- advanced or metastatic breast cancer patients, regardless of menopausal status. Furthermore, the FDA sanctioned its use in combination with fulvestrant for both first-line and second-line treatments in postmenopausal women suffering from advanced breast cancer.

Kisqali has proven to be a major revenue generator for Novartis, with sales reaching $2 billion last year and accumulating $1.34 billion in the first half of 2024. Projections by GlobalData indicate that the therapy’s global sales are expected to surpass $8 billion by 2030.

The recent label expansion was endorsed by favorable results from the open-label NATALEE trial (NCT03701334). Novartis disclosed an exploratory four-year analysis of this study at the European Society for Medical Oncology (ESMO) annual meeting earlier this week. The ESMO analysis revealed that the combination of Kisqali and endocrine therapy (ET) reduced the risk of cancer recurrence by 28.5% after three years of treatment compared to endocrine therapy alone.

Eli Lilly’s Verzenio (abemaciclib) stands as Kisqali’s primary competitor in the market. Similar to Kisqali, Verzenio is a CDK4/6 inhibitor tailored for the same breast cancer indications but is restricted to patients with nodal involvement. Last year, Verzenio achieved $3.86 billion in sales, and GlobalData forecasts that its sales will ascend to over $8.7 billion by 2030, slightly surpassing Kisqali’s projected sales within the same timeframe.