FDA Grants Inotuzumab Ozogamicin Priority Review for ALL

February 21st, 2017 – The FDA has granted a priority review designation to the anti-CD22 antibody-drug conjugate inotuzumab ozogamicin for the treatment of patients with relapsed or refractory acute lymphoblastic leukemia (ALL), based on findings from the phase III INO-VATE trial. Under the priority review program, the FDA will decide on the biologics license application for inotuzumab ozogamicin within 6 months compared with the standard 10-month … (leggi tutto)