Ribociclib Receives FDA Breakthrough Therapy Designation as First-line Treatment for HR+/HER2- Advanced Breast Cancer

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to ribociclib (LEE011) in combination with Femara® (letrozole) for the treatment of hormone receptor positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer.1

Ribociclib is a selective cyclin dependent kinase inhibitor, a new class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated in a cell, can enable cancer cells to grow and divide too quickly.

Breakthrough Therapy designation is intended to expedite the development and review of potential new medicines that treat serious or life-threatening conditions, if the therapy has demonstrated substantial improvement over an available therapy on at least one clinically significant endpoint. The designation includes all of the Fast Track program features, as well as more intensive FDA guidance on an efficient drug development program.

The Breakthrough Therapy designation is based primarily on positive results of the Phase III MONALEESA-2 trial of ribociclib  in combination with Femara in postmenopausal women who had received no prior therapy for their advanced disease. The MONALEESA-2 trial met the primary endpoint of clinically meaningful improvement delaying cancer progression. Results from the MONALESSA-2 trial will be presented at an upcoming medical meeting.2



  1. Novartis Press Release. Novartis CDK4/6 inhibitor LEE011 (ribociclib) receives FDA Breakthrough Therapy designation as first-line treatment for HR+/HER2- advanced breast cancer. Accessed August 3, 2016. Available https://www.novartis.com/news/media-releases/novartis-cdk46-inhibitor-lee011-ribociclib-receives-fda-breakthrough-therapy
  1. Novartis Press Release. MONALEESA-2 trial of Novartis’ LEE011 (ribociclib) stopped due to positive efficacy results at interim analysis in HR+/HER2- advanced breast cancer. Accessed August 3, 2016. Available https://www.novartis.com/news/media-releases/monaleesa-2-trial-novartis-lee011-ribociclib-stopped-due-positive-efficacy

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