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

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



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

The U.S. Food and Drug Administration today approved Kisqali (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 Kisqali in combination with fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy. Continue reading...