Ibtrozi: how long were the pivotal tox studies?

“GLP-compliant 28-day and pivotal 85-day toxicity and TK studies in rats and monkeys confirmed that taletrectinib produced target organ toxicity that would be anticipated for a typical TKI.”

“The Applicant evaluated the safety of taletrectinib administered orally once daily in 28-day and 12-week good laboratory practices (GLP)-compliant general toxicology studies using rats and cynomolgus monkeys.”

“The oral route of administration is consistent with the intended clinical route of administration.”