Cyramza: which tox species, and why?

“Ramucirumab binds only to human and non-human primate VEGFR2, thus a single species was used for the toxicological assessment of the antibody.”

“The Cynomolgus monkey can be considered an appropriate nonclinical species for ramucirumab toxicity testing given the comparable binding affinity of ramucirumab to its receptor in humans and Cynomolgus monkeys, and the fact that pharmacological effects have been seen in this test species.”

“A rat-anti mouse flk-1 monoclonal IgG1 antibody, DC101, was developed for use in in vivo studies.”

“Ramucirumab binds only to human and non-human primate VEGFR2, thus a single species was used for the toxicological assessment of the antibody.”

“Genotoxicity, carcinogenicity, developmental or reproductive toxicology studies were not conducted with ramucirumab in line with available guidance [ICH S9 (EMEA/CHMP/ICH/646107/2008)] as ramucirumab is indicated for the treatment of patients with advanced gastric cancer.”

“In accordance with ICH S9 the Applicant did not conduct carcinogenicity studies with ramucirumab because these studies are not warranted to support marketing for therapeutics intended to treat patients with advanced cancer.”

“A rat-anti mouse flk-1 monoclonal IgG1 antibody, DC101, was developed for use in in vivo studies.”