In a female fertility and early embryonic development study, female rats were administered daily intravenous doses of inotuzumab ozogamicin up to 0.11 mg/m2 for 2 weeks before mating through Day 7 of pregnancy. An increase in the proportion of resorptions and decrease in the number of viable embryos and gravid uterine weights were observed at the 0.11 mg/m2 dose level (approximately 2 times the exposure in patients at the maximum recommended dose, based on AUC). Additional findings in female reproductive organs occurred in repeat-dose toxicology studies and included decreased ovarian and uterine weights, and ovarian and uterine atrophy. Findings in male reproductive organs occurred in repeat-dose toxicology studies and included decreased testicular weights, testicular degeneration, hypospermia, and prostatic and seminal vesicle atrophy. Testicular degeneration and hypospermia were nonreversible following a 4-week nondosing period. In the chronic studies of 26-weeks duration, adverse effects on reproductive organs occurred at ≥0.07 mg/m2 in male rats and at 0.73 mg/m2 in female monkeys [see ]. . mitigation strategy (REMS) for the new molecular entity Besponsa (Inotuzumab Ozogamicin) is necessary to ensure the benefits outweigh its risks. Pfizer, Inc., submitted a Biologic Licensing. In clinical studies of BESPONSA in patients with relapsed or refractory ALL, the immunogenicity of BESPONSA was evaluated using an electrochemiluminescence (ECL)-based immunoassay to test for anti-inotuzumab ozogamicin antibodies. For patients whose sera tested positive for anti-inotuzumab ozogamicin antibodies, a cell-based luminescence assay was performed to detect neutralizing antibodies..