“Monkeys were dosed in GLP-compliant repeat-dose general toxicology studies for 3 or 13 weeks with IV bolus doses of 0, 1, 3, or 10 mg/kg belantamab mafodotin, with 12-week recovery periods.”
✓ VerifiedFDA multi-discipline review (BLA 761158, 2020 accelerated approval (withdrawn 2023; approved again Oct 2025)), p. 31Source ↗
Longest repeat-dose study and recovery
13-week rat (IV q3w) and monkey (IV weekly) GLP studies, each with 12-week recovery
“The 3-week and 13-week rat studies utilized weekly and every 3 weeks (q3w) dosing regimens, respectively. Monkeys were dosed in GLP-compliant repeat-dose general toxicology studies for 3 or 13 weeks with IV bolus doses of 0, 1, 3, or 10 mg/kg belantamab mafodotin, with 12-week recovery periods.”
✓ VerifiedFDA multi-discipline review, p. 31Source ↗
Pivotal GLP studies
GLP IV: rat 3-week (weekly) and 13-week (q3w); monkey 3- and 13-week (weekly); 12-week recovery
“The 3-week and 13-week rat studies utilized weekly and every 3 weeks (q3w) dosing regimens, respectively. Monkeys were dosed in GLP-compliant repeat-dose general toxicology studies for 3 or 13 weeks with IV bolus doses of 0, 1, 3, or 10 mg/kg belantamab mafodotin, with 12-week recovery periods.”
✓ VerifiedFDA multi-discipline review (BLA 761158, 2020 accelerated approval (withdrawn 2023; approved again Oct 2025)), p. 31Source ↗
Route in tox
Intravenous (rat 10-minute infusion; monkey IV bolus)
“rats were dosed for 3 or 13 weeks with intravenous (IV) doses (10-minute infusion) of 0, 3, 10, or 30 mg/kg belantamab mafodotin”
✓ VerifiedFDA multi-discipline review (BLA 761158, 2020 accelerated approval (withdrawn 2023; approved again Oct 2025)), p. 30Source ↗