Thyrogen Profile

Thyrogen® (thyrotropin alfa for injection) is a highly purified recombinant source of human thyroid stimulating hormone (rhTSH) developed for use in well-differentiated thyroid cancer patients who have had near-total or total thyroidectomy, and who must therefore take thyroid hormones and undergo periodic testing for recurrent or persistent cancer. Thyrogen raises serum TSH levels exogenously, stimulating I-131 uptake and thyroglobulin (Tg) production and release by cells of thyroid origin.^[1]

Thyrogen is indicated for use as an adjunctive diagnostic tool for serum Tg testing with or without radioiodine whole body scans (WBS) in the follow-up of patients with well-differentiated thyroid cancer.

Thyrogen is also indicated for use as an adjunctive treatment for radioiodine ablation of the thyroid tissue remnant in patients who have undergone a near total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of metastatic disease.

Potential clinical uses include:^[1]

• patients with undetectable on-suppression Tg
• patients who are unwilling to undergo withdrawal and whose physicians believe that use of a less sensitive test is justified
• patients with an inadequate endogenous TSH response, and,
• patients in whom withdrawal is contraindicated

For more information, please see the full prescribing information .

Genzyme and Thyrogen

Genzyme has been committed to helping patients with well-differentiated thyroid cancer since the 1980s, when they were among the first to research rhTSH. Further important milestones in Thyrogen's development include:

• 1987: Research on recombinant human thyroid stimulating hormone (rhTSH) leads researchers to begin development of thyrotropin alfa for injection
• 1991: Clinical trials begin
• 1997: NDA filed
• 1998: Thyrogen approved in U.S.
• 2000: Thyrogen approved in Europe
• 2005: Europe received approval for Thyrogen use in thyroid remnant ablation
• 2007: US received ablation approval for Thyrogen use in thyroid remnant ablation

To date, an estimated 350,000 patients worldwide have received Thyrogen,^[2] in 55 countries and Genzyme continues its commitment to thyroid cancer and other endocrine research.

REFERENCES:

1. Thyrogen (see full prescribing information). Cambridge, MA: Genzyme Corporation; 2001.

2. Genzyme Corporation. Data on file.