US Breakthrough Status for Novartis' Breast Cancer Drug


“Novartis’ experimental selective cyclin dependent kinase inhibitor LEE011 (ribociclib) has picked up a Breakthrough Therapy designation in the US for the treatment of certain forms of breast cancer.

“The drug is being developed for use alongside letrozole for the treatment of hormone receptor positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer.

“The award indicates the US Food and Drug Administration’s belief that LEE011 could potentially offer an improvement over an available therapy on at least one clinically significant endpoint, and is designed to help speed up its regulatory pathway to ensure quicker access for patients.”

Go to full article.

Do you have questions about this story? Let us know in a comment below. If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to use our Ask Cancer Commons service.