Another FDA 'Breakthrough' designation for Kisqali

The US Food and Drug Administration has granted Breakthrough Therapy designation to Kisqali (ribociclib) for initial endocrine-based treatment of pre- or perimenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in combination with tamoxifen or an aromatase inhibitor.

Swiss pharma giant Novartis’ (NOVN: VX) Kisqali is approved for use in more than 40 countries around the world, including the USA (in March 2017) and in Europe (August 2017). This is the second Breakthrough designation for Kisqali; the first was granted in August 2016 based on results of the Phase III MONALEESA-2 trial.

Kisqali competes with Pfizer’s Ibrance (palbociclib), which was approved in early 2016. EP Vantage, the editorial arm of the Evaluate group, has estimated sales of the drug $1.6 billion a year in 2022.