FDA Approves Expanded Use of Genzyme Thyroid Cancer Drug

By Anna Boyd
10:30, December 18th 2007
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FDA Approves Expanded Use of Genzyme Thyroid Cancer Drug

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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