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

“No genotoxicity studies have been conducted per ICH S6 and ICH S9 guidelines.”

“No carcinogenicity studies have been conducted. Zolbetuximab. is intended for the treatment of patients with advanced cancer in the scope of the ICH S9.”

“In an embryo-fetal development toxicity study, zolbetuximab was intravenously administered to pregnant mice during the period of organogenesis and did not result in embryo-fetal toxicity at doses up to 300 mg/kg (approximately 1.9 times the recommended clinical dose based on AUC).”

“In safety pharmacology studies with 100 mg/kg zolbetuximab, there were no CNS effects noted by Irwin’s test in mice. No cardiovascular or respiratory effects were observed in monkeys (Study 22337) at the highest dose of zolbetuximab (100 mg/kg) after once weekly IV administration for 4 weeks (5 doses in total).”