Ribociclib Receives Breakthrough Therapy Designation

August 4, 2016

The cyclin dependent kinase inhibitor received Breakthrough Therapy Designation as a first line treatment for advanced breast cancer.

Novartis’ cyclin dependent kinase (CDK4/6) inhibitor LEE011 (ribociclib) in combination with letrozole, received Breakthrough Therapy Designation from FDA as a first line treatment for hormone receptor positive, human epidermal growth factor receptor 2-negative advanced breast cancer (HR+/HER2-), the company said in an August 3, 2016 press announcement. This marks the company’s 11th Breakthrough Therapy Designation from FDA.

The Breakthrough Therapy designation is primarily based on results from a Phase III MONALEESA-2 trial in combination with letrozole. According to Novartis, Phase III trials met the primary endpoint for clinically meaningful improvement in progression free survival. If approved, the drug may be a direct competitor with Pfizer’s Ibrance (palbociclib), an oral inhibitor of cyclin-dependent kinases 4 and 6. In a Q2 earnings report, Pfizer noted Ibrance continued to perform strongly for the company.

Source: Novartis, Pfizer