FDA Approves Thyrogen For Use In Thyroid Cancer Ablation

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Thyroid Cancer Ablation

FDA has approved Genzyme's supplemental indication for Thyrogen (thyrotropin alfa for injection) to be used in combination with radioiodine to ablate, or destroy, the remaining thyroid tissue in patients who have had their cancerous thyroids removed. Remnant ablation is a procedure that patients commonly undergo when being treated for thyroid cancer.

"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," said Mike Heslop, senior vice president and general manager of Genzyme's endocrine business. "This is an important milestone in our ongoing effort to expand the clinical applications of Thyrogen to improve patient care."

The American Cancer Society estimates that in 2007, about 33,550 new cases of thyroid cancer will be diagnosed in the United States. Approximately 90 percent of all thyroid cancers are well-differentiated, making those patients candidates for the remnant ablation procedure.

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"The development of new treatment options for thyroid cancer patients is critical, as this disease has the fastest rising incidence of all cancers among women in the U.S.," said clinical investigator Paul Ladenson, M.D., professor and director of endocrinology at The Johns Hopkins University School of Medicine. "The availability of Thyrogen for use in remnant ablation is a notable advance, as it permits patients to maintain a good quality of life during the course of their thyroid cancer treatment and follow-up testing."

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 the recurrence of well-differentiated thyroid cancer. The product helps increase the sensitivity of testing while allowing patients to avoid the potentially debilitating symptoms of thyroid hormone withdrawal. Genzyme received additional European approval for Thyrogen's use during remnant ablation procedures in 2005.

Thyrogen Use in Ablation

The new indication allows Thyrogen to be used in conjunction with radioiodine for the most common approach to treating thyroid cancer. This includes surgical removal of the cancerous thyroid followed by remnant ablation, which destroys any remaining thyroid tissue. This can help reduce the risk of disease recurrence and facilitate follow-up monitoring.

In remnant ablation, patients take a drink or a capsule that contains radioactive iodine, which is taken up by any remaining thyroid cells. To enhance the uptake of radioiodine, the level of thyroid stimulating hormone (TSH) in a patient's bloodstream must be enhanced. Patients currently stop taking thyroid hormone supplements to elevate TSH levels. Doing so, however, often causes side effects associated with hypothyroidism, which may include fatigue, difficulty concentrating, short-term memory impairment and depression. Thyrogen is a recombinant form of TSH that is administered

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