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| |  FDA Approves Thyrogen For Thyroid Cancer CAMBRIDGE, MA -- Dec. 1, 1998 -- The United States Food and Drug Administration has approved Genzyme General’s Thyrogen(R) (thyrotropin alfa for injection) for use in follow-up screening of patients who have been treated for thyroid cancer. Thyrogen is indicated for use as an adjunctive diagnostic tool for serum thyroglobulin testing with or without radioiodine imaging in the follow-up of patients with well-differentiated thyroid cancer. This indication will allow physicians to use Thyrogen with a broad group of thyroid cancer patients. Serum thyroglobulin testing and radioiodine imaging are the two diagnostic procedures most commonly used with patients being examined for remnant thyroid tissue, thyroid cancer recurrence or metastases. In the U.S., physicians order approximately 135,000 thyroglobulin tests and 25,000 radioiodine imaging whole body scans each year for thyroid cancer patients. Thyrogen has been shown to significantly enhance the sensitivity of thyroglobulin testing in patients maintained on thyroid hormone therapy. Thyrogen also allows thyroid cancer patients to avoid the debilitating effects of hypothyroidism when undergoing radioiodine imaging scans. In a phase III clinical study, the combination of a Thyrogen-stimulated scan and a serum thyroglobulin test, although not as sensitive as combination testing performed after patients were withdrawn from thyroid hormone supplements, did detect all patients with metastatic disease. Patients who have had partial or total removal of their thyroid gland must take thyroid hormone supplements to maintain their metabolism and to suppress endogenous levels of thyroid stimulating hormone (TSH). However, a high level of TSH in a patient's bloodstream is necessary in order for radioiodine imaging to detect remnant thyroid tissue or metastatic disease and to achieve optimal sensitivity of serum thyroglobulin testing. Therefore, patients must stop taking their hormone supplements for two to six weeks prior to testing. This thyroid hormone withdrawal causes patients to experience fatigue, weight gain, constipation, mental dullness, lethargy, depression, and other adverse reactions. Thyrogen, which is a recombinant form of TSH, allows patients to avoid hormone withdrawal and its debilitating effects while undergoing diagnostic testing. The most common adverse events reported in clinical studies of Thyrogen were nausea and headache. Mild reactions of hypersensitivity consisting of urticaria and rash have also been reported. In clinical studies, no patients have developed antibodies to Thyrogen after either single or repeated use of the product.
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