Lymph node cellular depletion and increased white blood cells
“hematopoietic system (reduced RBCs and lineages, increased WBCs and differentials, increased platelets, and lymph node cellular depletion).”
✓ VerifiedFDA multi-discipline review, p. 33Source ↗
Biodistribution & persistence
Highest QWBA levels in small intestine, cecum and liver; crosses blood-brain barrier in rats
“A QWBA distribution study in rats demonstrated tissues with the highest radioactivity concentrations were small intestines, cecum, and liver. Olutasidenib crossed the blood brain barrier in rats with unbound ratios of cerebrospinal fluid to plasma and brain to plasma of 0.29 and 0.1, respectively.”
✓ VerifiedFDA multi-discipline review, p. 37Source ↗
Modality-specific risk
Phototoxicity linked to melanin binding
“Distribution studies showed binding of olutasidenib to melanin-containing tissues and a follow up phototoxicity study in rats showed erythema in the skin of animals after 48 hours of exposure to UV light that persisted for 72 hours.”
✓ VerifiedFDA multi-discipline review, p. 33Source ↗