Immune suppression from lymphoid depletion; decreased neutrophils and lymphocytes, matching clinical neutropenia and infections
“Hematology changes (decreased neutrophils and lymphocytes), immune suppression from lymphoid depletion, and GI toxicity observed in the toxicology studies correlated with neutropenia, infections, and GI toxicity observed in patients in the clinical trials.”
✓ VerifiedFDA multi-discipline review, p. 46Source ↗
Biodistribution & persistence
Prolonged retention in pigmented tissue (reversible melanin association); minimal brain distribution
“This longer presence in the pigmented tissue suggests a reversible association with melanin. There was minimal distribution of radioactivity into the brain of any animal used in the study”
✓ VerifiedFDA multi-discipline review, p. 58Source ↗