How this therapy can help

Kisqali^® is a selective CDK inhibitor, a new class of drugs that help slow the progression of cancer by inhibiting two proteins called CDK 4 and 6 (CDK4/6). These proteins, when over-activated in a cell, can enable cancer cells to grow and divide too quickly. Kisqali^® is the only CDK4/6 inhibitor, in combination with endocrine therapy, to show superior overall survival compared to endocrine therapy alone in advanced breast cancer.

Marketed product

Kisqali^® received US marketing approval by the FDA in March 2017 and by the EMA in August 2017 as a first-line drug treatment for postmenopausal women with HR+/HER2- advanced breast cancer in combination with an aromatase inhibitor. Full prescribing and safety information for Kisqali^® is available at www.kisqali.com.

Kisqali^® received US marketing approval in July 2018 and European marketing approval in December 2018 as a first-line drug treatment in combination with an aromatase inhibitor for the treatment of pre-, peri- or postmenopausal women with HR+/HER2- advanced or metastatic breast cancer and also for use in combination with fulvestrant as both first-line and second-line therapy in postmenopausal women.

Kisqali^® was approved as a treatment for early breast cancer by the U.S. Food and Drug Administration (FDA) in September 2024. In November 2024, Novartis received European Commission approval for Kisqali^® in a broad population of patients with HR+/HER2- early breast cancer at high risk of recurrence.

Kisqali^® has been approved as a treatment for metastatic breast cancer patients in 99 countries worldwide including by the U.S. FDA and the European Commission.

Clinical studies

Kisqali^® continues to be evaluated by Novartis in combination with a number of other endocrine agents in their on-going clinical trials program.