Jaypirca: which risks did reviewers probe?

“Effects on immune system function consisted of a shift in the balance of T, B, and NK lymphocytes, largely due to a decrease in B lymphocytes, and decreased TDAR response to KLH, a foreign antigen. With the exception of the anti-KLH TDAR in male rats, these effects were not considered adverse due to the lack of effect on the overall well-being of the animals.”

“The radioactivity declined over time to below the lower limit of quantitation (< 178 ng-eq) by 168 hours post dose for all tissues but the uveal tract and liver (294 and 262 ng-eq, respectively at 168 hours), with a calculated t1/2 of 66.4 and 56.1 hours, respectively.”

“Pirtobrutinib was positive for the induction of micronuclei under the conditions of this study at concentrations ≥ 12 µg/mL. Based on the high level of centromere-positive staining, the micronuclei were induced via a predominantly aneugenic mechanism (chromosome loss).”