European Commission (EC) Clears Wider Use for Genzyme Corporation Cancer Treatment
Published: Dec 07, 2012
“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.
"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 and societal costs, as demonstrated in the HiLo and ESTIMABL trials,” said Ujjal Mallick, M.D., Northern Centre for Cancer Care, Freeman Hospital, Newcastle UK.
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.
Thyrogen (thyrotropin alfa for injection) is for patients with well-differentiated thyroid cancer. Thyrogen is approved as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging. Thyrogen is also approved in the U.S. and Europe as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants in patients who have undergone a near total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of metastatic thyroid cancer.
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Ingrid Mitchell, 617-768-6699