Monjuvi: which tox species, and why?

“The safety of tafasitamab was evaluated in GLP-compliant 8- and 13-week general toxicology studies in cynomolgus monkeys.”

“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.”

“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.”

“The safety of tafasitamab was evaluated in GLP-compliant 8- and 13-week general toxicology studies in cynomolgus monkeys.”

“Based on a prior agreement with the FDA, the Applicant did not conduct reproductive and developmental toxicity studies with tafasitamab since tafasitamab is administered in combination with lenalidomide, a known teratogen and embryo-fetal toxicant.”

“Carcinogenicity studies are not necessary to support the marketing of therapeutics intended to treat patients with advanced cancer as discussed in the ICH S9 guidance document.”

“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.”