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 The company's shares fell as much as 15.7 percent to $52.18.
Six patients with acute myeloid leukemia (AML), a type of blood
cancer, have been identified with liver toxicity and four have died,
the company said on Tuesday.
The company is working with the FDA to identify whether the drug is
the cause of the toxicity.
The clinical holds on these early-stage AML trials have been
initiated to evaluate the potential risk of liver toxicity in
patients who were treated with the drug and underwent a stem cell
transplant either before or after the treatment.
"This outcome does place risk on whether the program is able to
continue", Guggenheim Partners' Tony Butler said.
The toxicity is "most likely drug dependent", and the company should
consider reducing the dose or dosing intervals to see if that
changes things, he added.
However, Needham & Co's Chad Messer cautioned investors not to
overreact noting that liver toxicity is a known side effect of stem
cell transplantation.
The drug, vadastuximab talirine, has been evaluated in more than 300
patients, and will continue to be tested in an ongoing late-stage
study in older AML patients, the company said.
The drug, which has been granted orphan drug designation by both the
U.S. FDA and the European Union for the treatment of AML, is also
being tested in patients with myelodysplastic syndrome, another form
of blood cancer.
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AML is a type of blood and bone marrow cancer that affects the
growth of immature blood cells. The disease is most common among
adults and tends to increase with age.
About 19,950 new cases of AML will occur in the United States in
2016, killing some 10,430, estimates the American Cancer Society.
Seattle Genetics, which already has an FDA-approved lymphoma drug
called Advetris, has been previously considered a takeover target.
Up to Friday's close, stock had risen about 52 pct in the last six
months.
(Reporting by Divya Grover in Bengaluru; Editing by Maju Samuel and
Shounak Dasgupta)
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