“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 ↗
Pivotal GLP studies
Cynomolgus monkey 8-week IV study (2, 10, 50 mg/kg every 2 weeks) and 13-week IV study (10, 30, 100 mg/kg weekly)
“once every two weeks at 2, 10 or 50 mg/kg in the 8-week study, or once every week at 0, 10, 30 or 100 mg/kg in the 13-week study.”
✓ VerifiedFDA multi-discipline review, p. 35Source ↗
Route in tox
Intravenous infusion
“All general toxicology studies performed used the intended route for human use (i.e., intravenous administration via infusion) and included concomitant toxicokinetics”