Unituxin: which tox species, and why?

“Animal studies exploring the safety of dinutuximab were conducted in Sprague Dawley rats and cynomolgus monkeys.”

“Though there were no histopathological indications of an effect of dinutuximab on peripheral nerves in this study, ch14.18 has been shown to bind to GD2 in rats.”

“Animal studies exploring the safety of dinutuximab were conducted in Sprague Dawley rats and cynomolgus monkeys.”

“Animal studies exploring the safety of dinutuximab were conducted in Sprague Dawley rats and cynomolgus monkeys.”

“Based on the median age of the proposed patient population (90% of patients less than 5 years of age), the Agency agreed that reproductive and developmental toxicology studies would not be required to support the BLA for Unituxin for the treatment of high risk neuroblastoma.”

“No carcinogenicity studies have been conducted.”

“The pharmacologic characterization of dinutuximab is based on published literature detailing experiments using ch14.18 and surrogate antibodies with the same variable domain but with alternative murine constant regions.”