Imjudo: genotox, carcinogenicity and repro: done or skipped?

“No studies were conducted in accordance with ICH S6(R1).”

“The Applicant did not conduct carcinogenicity or genetic toxicology studies as they are generally not appropriate for antibody therapies.”

“Under the conditions tested, there were no effects on maternal toxicity or embryo‐fetal mortality or malformations at doses up to 30 mg/kg administered once weekly during the period of organogenesis from GD20 to GD48 in an embryo‐fetal toxicity study in cynomolgus monkeys.”

“The FDA agrees that there were no tremelimumab‐related effects on cardiovascular, respiration, or central nervous system parameters in male and female cynomolgus monkeys at doses up to 50 mg/kg administered once weekly for up to 6 months.”