FDA Grants Ribociclib Breakthrough Designation for HR+/HER2- Premenopausal Breast Cancer

January 3, 2018 – The FDA has granted ribociclib a breakthrough therapy designation for use in combination with tamoxifen or an aromatase inhibitor (AI) as frontline treatment for pre- or perimenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer. The CDK4/6 inhibitor received the designation based on the phase III MONALEESA-7 trial. In the study, the median progression-free survival (PFS) was 23.8 months for women … (leggi tutto)