Blenrep: what was done before first-in-human, and what came after?

“The FDA notes that the 3-week (IND-enabling) and 13-week toxicology st udies conducted in monkeys with weekly dosing for belantamab mafodotin had comparable t oxicities and exposures.”

“The FTIH study DREAMM-1 evaluated dose levels from 0.03 to 4.6 mg/kg Q3W and selected 3.4 mg/kg Q3W based on emerging efficacy, safety, and pharmacokinetic data for evaluation in Part 2 of the study.”

“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.”

“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.”

“Reproductive and developmental studies have not been conducted since cytotoxic drugs such as belantamab mafodotin which target rapidly dividing cells, particularly in the bone marrow, are expected to be embryo/ fetotoxic and teratogenic. This position is consistent with ICH S9 guidance.”

“Reproductive and developmental studies were not conducted since cytotoxic (i.e. genotoxic) drugs such as belantamab mafodotin which target rapidly dividing cells, are expected to be embryo/feto toxic and teratogenic. This position is consistent with the ICH S9 guidance.”

“Reproductive and developmental studies were not conducted since cytotoxic (i.e. genotoxic) drugs such as belantamab mafodotin which target rapidly dividing cells, are expected to be embryo/feto toxic and teratogenic. This position is consistent with the ICH S9 guidance.”

“No carcinogenicity studies have been conducted to support the development of belantamab mafodotin.”

“The absence of carcinogenicity studies is accepted in line with the ICH S9 and S6(R1) guidelines.”

“The absence of carcinogenicity studies is accepted in line with the ICH S9 and S6(R1) guidelines.”