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| |  Europe Approves Thyrogen (Thyrotropin Alfa) for Use in Thyroid Cancer Ablation CAMBRIDGE, MA -- March 3, 2005 -- Genzyme Corporation (Nasdaq: GENZ) announced today that the European Commission has approved the company's marketing application for a therapeutic indication for Thyrogen (thyrotropin alfa for injection) when used in combination with radioiodine. The new label permits the product's use in the European Union for the ablation of remnant thyroid tissue, a procedure that patients commonly undergo when being treated for thyroid cancer. Genzyme is also seeking to add the ablation indication to the product's U.S. label and expects regulatory action on its submission in the second half of this year. Approximately 35,000 ablation procedures are performed annually in the United States and Europe combined, and Thyrogen has the potential to be used by up to 80 percent of these patients. "We believe that the use of Thyrogen in remnant ablation procedures can provide clear benefit for patients, and we are excited to now market the product in Europe for use in combination with radioiodine," said Mike Heslop, senior vice president and general manager of Genzyme's endocrine business. "This approval represents significant progress in our program to increase the potential clinical applications for Thyrogen." Genzyme established a commercial oncology franchise last year to address comprehensive cancer care from diagnosis to therapeutics to follow-up monitoring. Thyrogen is an important adjunct to thyroid cancer management because it can help lead to earlier detection of recurrence, which in turn may prevent deaths from this highly treatable disease. Thyrogen is currently indicated in the U.S. 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 associated with thyroid hormone withdrawal. Thyrogen Use in Ablation The new indication on the European label 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 a form of therapy known as remnant ablation that is designed to destroy any remaining thyroid tissue that may not have been removed during surgery, including any potentially cancerous cells in the thyroid bed. 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 elevated. 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, lethargy, difficulty concentrating, short-term memory impairment and depression. Thyrogen is a recombinant form of TSH that is administered by injection, allowing patients to continue taking hormone supplements and avoid the symptoms associated with hormone withdrawal. Results from a clinical study presented in June 2004 at the annual meeting of the Endocrine Society suggest that treatment with Thyrogen is similar to withdrawal from thyroid hormone in achieving ablation, and that it could significantly reduce the side-effects of thyroid hormone withdrawal by allowing patients to remain on hormone replacement therapy. The American Cancer Society estimates that more than 25,000 new cases of thyroid cancer will be diagnosed in the United States this year. It is three times more common in women than in men. Most cases of thyroid cancer are discovered during a routine physical examination when a painless lump is found in the thyroid. Although well-differentiated thyroid cancer is very treatable, ongoing monitoring is important as disease can recur in up to 30 percent of patients. About Thyrogen Thyrogen is currently approved in approximately 40 countries. It was first approved in the United States in 1998 as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging. Thyrogen was developed for use in patients with well-differentiated thyroid cancer who have had their thyroid gland removed. These patients must take thyroid hormone suppression therapy (THST) and undergo periodic testing for recurrent or metastatic cancer. Thyrogen allows patients to remain on their THST and avoid the potentially debilitating symptoms of clinical hypothyroidism. Thyrogen is used in combination with other tests to detect recurring or leftover thyroid cancer cells in patients with a history of well- differentiated thyroid cancer. Thyrogen is injected in a muscle, and is available only by prescription. The most common side effects reported in clinical studies were nausea, headache, weakness and vomiting. When using Thyrogen, there is a risk that thyroid cancer cells may not be detected and diagnosis of recurring cancer may be missed. To learn more, please see full product information, contact Genzyme at 1-800-745-4447 or visit http://www.thyrogen.com.
Genzyme® and Thyrogen® are registered trademarks of Genzyme Corporation. All rights reserved.
SOURCE: Genzyme Corporation
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