Adcetris: how long were the pivotal tox studies?

“The haematologic changes observed in the 26-week repeat-dose toxicity study were similar to those of the 11-week study.”

“With repeat-dose administration of brentuximab vedotin, unconjugated brentuximab, and MMAE in rats and monkeys the principal test article-related effects of brentuximab vedotin and MMAE in both species included changes in the bone marrow and lymphoid tissues;”

“Since SGN-35 has been developed for intravenous (IV) administration all non-clinical studies were conducted using the IV route of administration.”