Zepzelca: which tox species, and why?

“The Sprague Dawley rat, Beagle dog and Cynomolgus monkey were the main species used for toxicological assessment of lurbinectedin.”

“Despite using dogs in the initial 4-week toxicology studies, the Applicant utilized the monkey in the 13-week non-rodent toxicology study due to metabolic data suggesting that monkey metabolism was more similar to human than other tested non-rodent species.”

“Intravenous administration of PM01183 at the dose of 0.125 mg/kg every 3 weeks for 8-cycles was not tolerated by Cynomolgus monkeys”

“The Sprague Dawley rat, Beagle dog and Cynomolgus monkey were the main species used for toxicological assessment of lurbinectedin.”

“Given its mechanism of action as a genotoxic agent targeting rapidly dividing cells, FDA would not generally request an embryofetal development study, however, the Applicant did conduct a preliminary single dose, single-dose level embryo-fetal development study in rats.”

“The Applicant did not conduct carcinogenicity studies based on the proposed patient population.”

“The Sprague Dawley rat, Beagle dog and Cynomolgus monkey were the main species used for toxicological assessment of lurbinectedin.”