Genzyme, a Sanofi company (NYSE: SNY) said the European Commission approved the expanded indication for use of Thyrogen.
European Commission approved a product label expansion for the use of Thyrogen with a wider irradiation dose range for postoperative thyroid remnant ablation.
According to Genzyme, the revised indication in remnant ablation provides physicians with the option to administer a reduced dose of radioiodine (131-I). Previously the amount of radioiodine was specified at 100 mCi, whereas physicians may now select a dose from the range of 30 to 100 mCi.
"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," said Professor Martin Schlumberger, Institut Gustave Roussy, University Paris Sud, Paris, France.
The approval for the expanded indication for use of Thyrogen in Europe is based on the results of the two largest studies, which showed 30 mCi of radioiodine were well tolerated.
Thyrogen is approved as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging.
In the U.S. and Europe, Thyrogen is also approved 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.