“The safety of tafasitamab was evaluated in GLP-compliant 8- and 13-week general toxicology studies in cynomolgus monkeys.”
✓ VerifiedFDA multi-discipline review, p. 34Source ↗
Why that species
Comparable binding to human, cynomolgus and rhesus CD19+ lymphocytes; low binding in rat and mouse, none in dog and rabbit
“Binding of tafasitamab-FITC to human, cynomolgus monkey and rhesus monkey lymphocytes was comparable. Tafasitamab showed lower binding to rat and mouse, and no binding to dog and rabbit lymphocytes.”
✓ VerifiedFDA multi-discipline review, p. 36Source ↗
Surrogate molecule
No surrogate; the clinical antibody was tested in cynomolgus monkeys
“The studies were all conducted in cynomolgus monkeys (Macaca fascicularis), due to lack of tafasitamab antibody binding to lymphocytes in other common laboratory animal species.”