Lymphoid atrophy with decreased thymus weights in dogs at all doses
“Decreased thymus weights correlated with lymphoid atrophy in males and females at all doses.”
✓ VerifiedFDA multi-discipline review, p. 34Source ↗
Biodistribution & persistence
Rat eye uveal tract radioactivity peaked at 168 h and was sustained through 672 h
“The eye uveal tract had a Cmax of 19,500 ng eq/g at 168 hours post-dose at concentrations that were sustained through 672 hours post-dose.”
✓ VerifiedFDA multi-discipline review, p. 44Source ↗
Modality-specific risk
QTc prolongation via hERG inhibition by revumenib and metabolite M1
“Based on findings from non-GLP and GLP assays, revumenib and its primary metabolite M1 have the potential to block the hERG channel and contribute to QTc prolongation.”
✓ VerifiedFDA multi-discipline review, p. 32Source ↗