FDA imposes clinical hold on Seattle Genetics' cancer drug after 4 deaths

The Food and Drug Administration is imposing a clinical hold on several of Seattle Genetics' early-stage studies involving an experimental cancer drug following the deaths of four people, Reuters reported. 

Four patients with acute myeloid leukemia died from liver toxicity, while six others have been identified with the condition, the company disclosed Dec. 27. Seattle Genetics is working with the FDA to identify whether the drug caused the toxicity.

The clinical holds have been implemented to assess the potential risk of liver toxicity in patients who were treated with the drug and underwent a stem cell transplant either before or after treatment, according to the report.

The drug, vadastuximab talirine, has been evaluated in more than 300 patients. Seattle Genetics said it will continue to test the drug in ongoing late-stage study among older AML patients. It is also being tested in patients with myelodysplastic syndrome, another form of blood cancer, according to the report.

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