Genzyme Gets EU Approval of Thyrogen for Use in Thyroid Cancer Ablation

Genzyme has announced that the European Commission has approved the company's marketing application for a therapeutic indication for Thyrogen when used in combination with radioiodine.

The new label permits the product's use in the European Union for the ablation of remnant thyroid tissue, a procedure that patients commonly undergo when being treated for thyroid cancer.

Genzyme is also seeking to add the ablation indication to the product's U.S. label and expects regulatory action on its submission in the second half of this year. Approximately 35,000 ablation procedures are performed annually in the U.S. and Europe combined, and Thyrogen (thyrotropin alfa for injection) has the potential to be used by up to 80 percent of these patients.