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”