Kisqali Granted Breakthrough Therapy Status to Treat Breast Cancer in Premenopausal Women

Kisqali Granted Breakthrough Therapy Status to Treat Breast Cancer in Premenopausal Women
The U.S. Food and Drug Administration (FDA) has granted Kisqali (ribociclib) Breakthrough Therapy designation for the treatment of premenopausal women with HR-positive, HER2-negative advanced breast cancer who have not received prior endocrine treatment, according to Novartis. The designation, designed to expedite the development and review of treatments for serious or life-threatening conditions, was granted to Kisqali in combination with tamoxifen or an aromatase inhibitor. Kisquali is approved in the U.S., the E.U., and many other countries for postmenopausal women with HR-positive, HER2-negative metastatic breast cancer. Novartis is seeking approval of the therapy for women who have not reached menopause or who are in menopause transition (perimenopausal). The FDA's Breakthrough Therapy designation for Kisqali in premenopausal women with advanced cancer was based on positive results from the MONALEESA-7 Phase 3 trial (NCT02278120), which were presented in December at the San Antonio Breast Cancer Symposium (SABCS). "This Breakthrough Therapy designation reflects the significance and promise of the MONALEESA-7 data presented at SABCS last month," Samit Hirawat, MD, head of Novartis Oncology Global Drug Development, said in a
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