Blincyto: how long were the pivotal tox studies?

“Therefore, in the 13-week repeat-dose toxicology study in mice, BALB/c mice were administered muS103new (0, 1, or 5 mg/kg/day; 0, 2, or 10 mg/kg/day) by subcutaneous injection twice daily with an 8-hour interval between doses for 13 weeks with a 4-week recovery period.”

“For this review, the 4-week (summarized) and 13-week studies of muS103new in mice and the 5-weekly dose study of blinatumomab in chimpanzees were reviewed.”

“The intended clinical route is intravenous infusion. Most animal studies were conducted with the intravenous route. The 13-week mouse study was conducted with subcutaneous administration; intravenous bolus injection was not considered feasible by the applicant for this study.”