New breast cancer drug Kisqali approved by FDA

The US Food and Drug Administration has approved Kisqali (ribociclib, formerly known as LEE011) in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.

Swiss pharma giant Novartis’ (NOVN: VX) Kisqali is a CDK4/6 inhibitor approved based on a first-line Phase III trial that met its primary endpoint early, demonstrating statistically significant improvement in progression-free survival (PFS) compared to letrozole alone at the first pre-planned interim analysis. Kisqali was reviewed and approved under the FDA Breakthrough Therapy designation and Priority Review programs.

Novartis plans to start shipping Kisqali to pharmacies as soon as today and will offer three doses, all on a 28-day treatment regimen. The wholesale acquisition cost (WAC) for a 28-day supply of the 600mg dose is set at $10,950, while the 400 mg will cost $8,760 and the 200 mg will cost $4,380. It will compete with Pfizer’s already marketed Ibrance (palbociclib). "At the time of launch, Kisqali will be the CDK 4/6 inhibitor with the lowest WAC price," Bill Hinshaw, head of US Oncology for Novartis, said on a conference call with journalists