Rezlidhia: genotox, carcinogenicity and repro: done or skipped?

“Olutasidenib was not genotoxic in the in vitro bacterial reverse mutation (Ames), in vitro human lymphocyte micronucleus, and in vivo rat bone marrow micronucleus assays.”

“Carcinogenicity of olutasidenib was not evaluated in accordance with ICH S9.”

“In embryo-fetal development studies, oral olutasidenib resulted in embryo-fetal death and altered fetal growth when administered to pregnant rats and rabbits during the period of organogenesis at exposures up to 10 times and 0.7 times, respectively, the human exposure at the recommended daily dose”

“The in vivo cardiovascular assessments were conducted as part of a 28-day repeat-dose general toxicology study in monkeys (2336-008). Consistent with hERG inhibition, olutasidenib was associated with a significant increase in corrected QT (QTc) interval duration at the high dose (300/200/100 mg/kg/day), which became progressively longer with repeated dosing.”