World's first Kinase 4/6 (CDK 4/6) inhibitor breast cancer drug approved in China

The China National Drug Administration (CNDA) has granted approval of Ibrance(palbociclib), the first cyclin-dependent Kinase 4/6 (CDK4/6) inhibitor, for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2) advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women, according to statement today from US pharma giant Pfizer’s (NYSE: PFE) local subsidiary.

Ibrance is the world's first Kinase 4/6 (CDK 4/6) Inhibitor and the only innovative breakthrough therapy for advanced breast cancer in China over past 10 years. The five-year survival rate of advanced BC patients is only 20%, and no significant improvement in treatment solutions has been made in the past 10 years.

CDK4/6 inhibitors have become a new and hot target in recent years. In 2015, the world's first CDK4/6 inhibitor, Pfizer's Ibrance was approved by the US Food and Drug Administration. The US FDA has also approved two other CDK4/6 inhibitor drugs: Novartis's (NOVN: VX) Kisqali (ribociclib) and Eli Lilly's (NYSE: LLY) Verzenio (abemaciclib), though these two have not been approved as yet in China.