LEE011 (ribociclib, a selective cyclin dependent kinase inhibitor developed by Novartis, was granted Priority Review by FDA. FDA also accepted Novartis’s new Drug Application for filing as first-line treatment of postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer in combination with letrozole. The NDA is based on...
LEE011, Novartis’s selective cyclin dependent kinase inhibitor, granted FDA Priority Review
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