“Dose and frequency of dosing: 0, 2.5, 10, or 40 mg/kg; test article was administered once weekly for 26 weeks”
✓ VerifiedFDA multi-discipline review, p. 30Source ↗
Pivotal GLP studies
GLP cynomolgus monkey 26-week once-weekly IV study (2.5, 10, 40 mg/kg), plus 4-week study
“In the 26-week study, mogamulizumab was administered IV at doses of 2.5, 10, or 40 mg/kg once weekly. Mogamulizumab was well-tolerated, and no adverse mogamulizumab-related changes were observed.”
✓ VerifiedFDA multi-discipline review, p. 23Source ↗
Route in tox
IV (bolus)
“Route of administration: IV (bolus)”
✓ VerifiedFDA multi-discipline review, p. 30Source ↗