Genzyme Receives European Label Expansion for Thyrogen
“It has long been debated whether smaller amounts of radioiodine for patients with low-risk thyroid cancer would improve care,” said Professor Martin Schlumberger, M.D., Institut Gustave Roussy, University Paris Sud, Paris, France. “The expanded Thyrogen indication provides a new option for many physicians who may be reducing radioiodine use due to uncertainty about impact on recurrences and mortality in low-risk patients as well as short- and long-term safety concerns.”
The decision to approve the expanded indication for use of Thyrogen in Europe is based on the results of the two largest studies (HiLo and ESTIMABL) ever conducted in thyroid remnant ablation. The studies, published in the New England Journal of Medicine in May 2012, evaluated whether rates of successful ablation would be similar among patients receiving recombinant human thyrotropin (rhTSH), patients undergoing thyroid hormone withdrawal (THW), and among patients receiving low or high amount of radioiodine.
In the two studies, 30 mCi of radioiodine were well tolerated and showed similar success rates for low-dose radioiodine plus rhTSH vs. high-dose plus THW or rhTSH. In both studies, patients receiving Thyrogen rather than THW had fewer hypothyroid symptoms and better preserved quality of life.
These findings have been reflected in the updated Summary of Product Characteristics (SmPC) and apply to all 27 EU member states, plus Iceland and Norway.
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