Slammed by more deaths, Seattle Genetics scraps a PhIII study and pulls back (again) on vadastuximab
Just three months after the FDA lifted a clinical hold on its late-stage cancer drug vadastuximab talirine (SGN-CD33A), the biotech abruptly scrapped a Phase III study and halted enrollment across a slate of studies after independent monitors tracked a higher rate of deaths among patients taking its drug.
The deaths in the study — for frontline use against acute myeloid leukemia — included fatal infections but were evidently not associated with liver toxicity, which had already killed 4 patients, forcing the FDA to hit the brakes on the study in late December, 2016.
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