Lazcluze: which tox species, and why?

“The Applicant evaluated the safety of lazertinib using Sprague-Dawley rats and Beagle dogs in GLP-compliant oral repeat-dose toxicology studies of up to 13-weeks duration.”

“Overall, the PK profile in rats and dogs appears to be well described, and comparisons with human PK data supported the rat and dog as relevant non-clinical species for testing toxicity.”

“In the 13-week dog study, one high dose (8 mg/kg; approximately 2 times the clinical AUC at the 240 mg human dose) male dog was euthanized on Day 70”

“The Applicant evaluated the safety of lazertinib using Sprague-Dawley rats and Beagle dogs in GLP-compliant oral repeat-dose toxicology studies of up to 13-weeks duration.”

“The Applicant conducted GLP-compliant embryo-fetal development studies in Sprague-Dawley rats and New Zealand White rabbits.”

“The Applicant did not conduct carcinogenicity studies to support the currently proposed indication (NSCLC), and these studies are not needed to support a marketing application for a drug intended to treat patients with advanced cancer.”

“The Applicant evaluated the safety of lazertinib using Sprague-Dawley rats and Beagle dogs in GLP-compliant oral repeat-dose toxicology studies of up to 13-weeks duration.”