Gabe S. Sonke MD, PhD
Ribociclib, an orally bioavailable, selective cyclin-dependent kinase 4/6 inhibitor, demonstrated similar clinical benefits and safety profiles for both elderly and younger patients with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer, according to findings from a pre-planned subgroup analysis of data from the MONALEESA-2 trial.
The Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for ribociclib in August 2016 and has also accepted a New Drug Application (NDA) and granted priority review for ribociclib as firstline treatment of postmenopausal women with HR+/HER2- advanced or metastatic breast cancer in combination with letrozole. The NDA was based in part on results of the MONALEESA-2 trial, which was presented at the European Society for Medical Oncology (ESMO) 2016 Congress and published simultaneously in the New England Journal of Medicine.
Sonke, G.S.,Hart, L.L., Campone M, et al. Efficacy and safety of ribociclib (LEE011) + letrozole in elderly patients with hormone receptor-positive (HR+), HER2-negative (HER2˗) advanced breast cancer (ABC) in MONALEESA-2. Abstract presented at: 2017 European Cancer Congress; January 27-30, 2017; Amsterdam. Abstract 2LBA.
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