Rozlytrek: which tox species, and why?

“considering that the majority of toxicology studies, including the pivotal 13-week rat and dog studies, tested the Form II (A) also used in clinical trials, results from toxicology studies are considered reliable for extrapolation to humans.”

“Sequence comparisons showed 100% or near 100% sequence homologies in the entrectinib binding site, building confidence on the theoretical validity of the selected species used for the safety validation.”

“considering that the majority of toxicology studies, including the pivotal 13-week rat and dog studies, tested the Form II (A) also used in clinical trials, results from toxicology studies are considered reliable for extrapolation to humans.”

“considering that the majority of toxicology studies, including the pivotal 13-week rat and dog studies, tested the Form II (A) also used in clinical trials, results from toxicology studies are considered reliable for extrapolation to humans.”

“Dedicated fertility studies in animals have not been performed to evaluate the effect of entrectinib. No adverse effects of entrectinib on male and female reproductive organs were observed in the repeatdose toxicology studies in rats and dogs at approximately 2.4-fold and 0.6-fold, respectively, the human exposure by AUC at the recommended human dose. In an embryo-foetal developmental study in rats, maternal toxicity”

“No carcinogenicity studies have been performed to establish the carcinogenic potential of entrectinib.”

“considering that the majority of toxicology studies, including the pivotal 13-week rat and dog studies, tested the Form II (A) also used in clinical trials, results from toxicology studies are considered reliable for extrapolation to humans.”