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Genzyme Corp. said Monday that the Food and Drug
Administration (FDA) expanded the approved use of its thyroid cancer drug
Thyrogen.
Tyrogen was first approved in 1998 in the United States and in 2001 in Europe
as a diagnostic tool in the management of patients being tested for the
recurrence of well-differentiated thyroid cancer. Now, the drug was expended
for use in combination with radioiodine to destroy the remaining thyroid tissue
in patients who have had cancerous thyroids removed.
"This new indication extends the significant benefits of Thyrogen to
patients during their initial treatment for thyroid cancer, in addition to its
current use in follow-up diagnostic procedures to detect recurrence. This is an
important milestone in our ongoing effort to expand the clinical applications
of Thyrogen to improve patient care," said Mike Heslop, senior vice
president and general manager of Genzyme's endocrine business.
Genzyme received approval for the extended use in Europe
in 2005. Almost 90 percent of all thyroid cancers potentially fall within the
new use category, the company said.
According to the American Cancer Society, almost 33,550 new
cases of thyroid cancer are expected to be diagnosed in 2007 in the United States.
Shares of Genzyme rose 2 cents to $74.89 in morning trading.
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