FDA Approves Genzyme's Thyrogen Label Revision
Sanofi company Genzyme announced that the Food and Drug Administration (FDA) has approved its application to revise prescribing information for the use of Thyrogen (thyrotropin alfa for injection).
Thyrotropin alfa has been previously used before radioiodine (RAI) treatment to improve uptake of the radiotracer and allow patients to begin and maintain thyroid hormone replacement therapy. This helps in avoiding untoward effects associated with hypothyroidism. The approval allows Genzyme to widen the dose range of RAI when used for thyroid remnant ablation. As the amount of RAI was previously fixed at 100 mCi, physicians may now select a dose from the range of 30-100 mCi.
Bryan Haugen, M.D., Professor of Medicine at the University of Colorado and immediate past President of the American Thyroid Association, said, “The incidence of thyroid cancer is rapidly increasing in the United States. Today’s FDA revision to widen the administered dose range of RAI for patients being prepared for remnant ablation with Thyrogen allows important management flexibility for physicians and treatment options for patients.”
The revision in the prescribing information for Thyrogen in ablation was based on data from two of the largest prospective studies ever conducted in thyroid cancer. Ujjal Mallick, M.D., Northern Centre for Cancer Care, Freeman Hospital, Newcastle UK, said, “The best path to achieve thyroid remnant ablation must be one that involves the least whole body radiation dose, the least early and late side-effects, the best quality of life, and the least healthcare costs, as demonstrated in the these two landmark studies.”
Thyrogen is indicated in patients with well-differentiated thyroid cancer. The drug is approved in the U.S. and Europe as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants in patients who have had an almost total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer.