Novartis CDK4/6 Inhibitor Receives FDA Breakthrough Status for Breast Cancer


Novartis’ CDK4/6 inhibitor, LEE011 (ribociclib) received Breakthrough Therapy Designation from FDA as a first line treatment for HR+/HER2- advanced breast cancer.

Novartis pharma logoIt is the 11th Breakthrough Therapy Designation received by NovartisThe promising results in Phase III clinical study of LEE011 combined with letrozole compared to letrozole alone in postmenopausal women with HR+/HER2- advanced breast cancer who had not received any previous therapy supported the breakthrough designation. A pre-planned interim analysis demonstrated clinically significant improvement in progression-free survival (PFS).

ribociclib letrozole

LEE011 is a small-molecule, oral, selective cyclin dependent kinase (CDK) inhibitor which is a novel class of drugs that helps in reduction of the progression of cancer by the inhibition of two proteins called cyclin dependent kinase 4 and 6 (CDK4/6). The overexpression of these proteins in a cell can activate the cancer cells to grow and divide too quickly.

role of CDK4 CDK 6 in breast cancer

Figure 1. Inhibition of Cyclin-Dependent Kinases 4 and 6 in Breast Cancer (photo credit: Clin Adv Hematol Oncol. 2015 Apr;13(4):215-7).  

astex pharmaceuticals logoLEE011 was developed by Novartis Institutes for BioMedical Research (NIBR) under research collaboration with Astex Pharmaceuticals.

Further clinical trials are going on under Phase III study for the elaborated study of the safety, efficiency and tolerability and overall survival data of LEE011. The complete result of the study will be presented at the upcoming medical congress and will help in the regulatory decisions in US, Europe and other countries. The drug is not approved in the market for any indication till now.

Earlier this year, US-based Radius Health collaborated with Novartis AG to evaluate the safety and efficacy of its RAD-1901 along with Novartis’ LEE011. RAD-1901 is intended for the treatment of patients suffering from advanced estrogen receptor positive and HER2 negative (ER+/HER2-) breast cancer.

Despite advancements in treatment, an estimated 40,000 individuals in the United States die each year from advanced breast cancer,” said Alessandro Riva, MD, Global Head, Oncology Development and Medical Affairs, Novartis Oncology. “This designation shows the potential of LEE011, and we look forward to close collaboration with the FDA and the advanced breast cancer community to provide a new treatment option for women living with HR+/HER2- advanced breast cancer as quickly as possible“.

Featured Image Credit: Novartis – Fabrikstrasse 15, Gehry Building,

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