Abstract
Farletuzumab is a humanized monoclonal antibody targeting human folate receptor alpha, which is being developed as an anti-cancer drug. A non-human primate reproductive study was conducted to evaluate whether it could cause any embryonic or fetal abnormalities. Farletuzumab was administered intravenously to pregnant cynomolgus monkeys (n = 16/group) at doses of 0 or 67.5 mg/kg once weekly during gestation day (GD) 20 through 97. C-section was performed on GD100 ± 2, and fetuses were evaluated for morphologic (external, visceral and skeletal) effects. No farletuzumab-related changes were observed in maternal animals or fetuses, which are supported by the fact that farletuzumab has no effects on cellular uptake of folate. These data support the potential use of farletuzumab for oncologic indications during pregnancy.
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