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

“Genotoxicity assays are not recommended for biological therapeutics. An Ames assay was conducted, and results were negative.”

“Carcinogenicity studies were not required because ublituximab is not active in rodent; therefore, standard carcinogenicity studies are not feasible.”

“Weekly intravenous administration of ublituximab-xiiy (0 or 30 mg/kg) to pregnant monkeys during the first, second, or third trimester of pregnancy produced a severe immunogenic response in dams, resulting in maternal morbidity and death and embryofetal loss.”

“There were no observed clinical findings concerning cardiac, respiratory, or CNS safety pharmacology in the general toxicology studies.”