FDA Approves Thyrogen® for Use in Thyroid Cancer Ablation12/2007
In December 2007, the U.S. Food and Drug Administration (FDA) approved the use of Thyrogen® (thyrotropin alfa for injection) in combination with radioiodine to ablate, or destroy, the remaining thyroid tissue in patients who have had their cancerous thyroids removed.
Remnant ablation often follows some weeks after surgery in people being treated for differentiated thyroid cancer—papillary, follicular, or variants.
In 2007, about 33,550 new cases of thyroid cancer were estimated in the United States. About 90 percent of all thyroid cancers are well-differentiated, making those patients candidates for the remnant ablation procedure.
Thyrogen was initially approved in the U.S. in 1998 and Europe in 2001 for use as a diagnostic tool in the management of patients being tested for persistent disease or recurrence of well-differentiated thyroid cancer. The product is used instead of thyroid hormone withdrawal, to allow patients to avoid the weeks of symptoms that often accompany thyroid hormone withdrawal. Genzyme, the manufacturer of Thyrogen®, received additional European approval for Thyrogen's use during remnant ablation procedures in 2005.
Thyrogen® is currently available in more than 45 countries.