FDA Approves Inotuzumab Ozogamicin for ALL

August 17, 2017 – The FDA has approved inotuzumab ozogamicin for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), based on findings from the phase III INO-VATE trial. The approval comes with a boxed warning for hepatotoxicity and warning of an increased risk of death following certain types of stem cell transplant. In the phase III study, 326 patients were enrolled, with the approval based on data from the first … (leggi tutto)