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REFILE-FDA puts clinical hold on Seattle Genetics' cancer drug after 4 deaths
December 27, 2016 / 1:24 PM / 9 months ago

REFILE-FDA puts clinical hold on Seattle Genetics' cancer drug after 4 deaths

(Corrects to ‘Tuesday’ from ‘Monday’ in first paragraph)

Dec 27 (Reuters) - Seattle Genetics Inc said on Tuesday that four people had died in trials testing its experimental cancer drug, prompting the U.S. Food and Drug Administration to impose a clinical hold on several early-stage trials.

The drug, vadastuximab talirine, is being tested to treat acute myeloid leukemia, a type of blood cancer.

Six patients have been identified with liver toxicity, and four have died, the company said.

The clinical holds have been initiated to evaluate the potential risk of liver toxicity in patients who were treated with the drug and underwent stem cell transplant surgery either before or after the treatment. (Reporting by Divya Grover in Bengaluru; Editing by Shounak Dasgupta)

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