Lartruvo: which tox species, and why?

“In in vitro studies, olaratumab bound to human and cynomolgus monkey PDGFR-α with similar affinity, but did not bind appreciably to mouse or rabbit PDGFR-α, supporting the use of cynomolgus monkeys as the single pharmacologically relevant species for toxicity assessment.”

“In in vitro studies, olaratumab bound to human and cynomolgus monkey PDGFR-α with similar affinity, but did not bind appreciably to mouse or rabbit PDGFR-α, supporting the use of cynomolgus monkeys as the single pharmacologically relevant species for toxicity assessment.”

“the Applicant provided a scientific literature review and assessment of the potential reproductive toxicity of olaratumab in conjunction with an embryo-fetal development study in mice using a chimeric surrogate antibody, IMC-1E10.”

“Olaratumab was evaluated in GLP-compliant repeat-dose toxicology studies in cynomolgus monkeys of up to 39 weeks in duration.”

“the Applicant provided a scientific literature review and assessment of the potential reproductive toxicity of olaratumab in conjunction with an embryo-fetal development study in mice using a chimeric surrogate antibody, IMC-1E10.”

“Not conducted per ICH S6, ICH S1, and ICH S9.”

“the Applicant provided a scientific literature review and assessment of the potential reproductive toxicity of olaratumab in conjunction with an embryo-fetal development study in mice using a chimeric surrogate antibody, IMC-1E10.”