Seattle Genetics abruptly ended the holiday vibes on Tuesday with news that the FDA had placed several clinical trials for its investigational drug vadastuximab talirine on hold, following six severe adverse events and four fatalities.
The deaths occurred in a Phase 1/2 trial of vadastuximab in relapsed acute myeloid leukemia (AML). Notably, these patients also received an allogeneic stem cell transplant, either before or after treatment.