Monjuvi: genotox, carcinogenicity and repro: done or skipped?

“Genotoxicity studies are generally not necessary to support marketing of biotechnology-derived pharmaceuticals such as tafasitamab as discussed in the ICH S6 guidance document.”

“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.”

“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.”

“Monitoring of safety pharmacology parameters for vital organ functions (cardiovascular, respiratory and central nervous system) was incorporated into the 8-week and 13-week repeat-dose toxicology studies in cynomolgus monkeys”