Monkey immune activation with fibrinogen elevation, thymic toxicity and myelosuppression
“Findings included GI toxicity, myelosuppression, thymic toxicity, electrolyte imbalance, and immune activation (elevated fibrinogen was secondary to immune activation).”
✓ VerifiedFDA multi-discipline review, p. 34Source ↗
Biodistribution & persistence
Mouse QWBA: widespread distribution, highest in tissues of excretion and elimination
“In a mouse QWBA study, distribution of [14C]-daraxonrasib was widespread with the highest concentrations of radioactivity generally associated with tissues involved in excretion and elimination.”
✓ VerifiedFDA multi-discipline review, p. 43Source ↗
Modality-specific risk
Bone marrow, gastrointestinal and immune/hematologic toxicity
“The primary target organs across both species included bone marrow, gastrointestinal tract and immune/hematologic systems.”
✓ VerifiedFDA multi-discipline review, p. 49Source ↗