FDA Approval Sought for Venetoclax/Obinutuzumab Combo for Frontline CLL

March 7, 2019 – A supplemental new drug application (sNDA) has been filed for the combination of venetoclax and obinutuzumab for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL) who also have coexisting medical conditions. The submission is based on findings from the randomized, phase III CLL14 study, in which a fixed-duration combination of venetoclax and obinutuzumab demonstrated a statistically significant … (leggi tutto)