FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency

July 18, 2018 – The U.S. Food and Drug Administration today approved ribociclib in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. The FDA also approved ribociclib in combination with fulvestrant for the treatment of postmenopausal women with … (leggi tutto)