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news.Genzyme Corporation's Thyrogen has received European marketing approval by the European Commission for use in thyroid cancer ablation when used in combination with radioiodine.
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The new label for Thyrogen (thyrotropin alfa for injection) permits the product’s use in the EU 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 US label and expects regulatory action on its submission in the second half of this year.
“We believe that the use of Thyrogen in remnant ablation procedures can provide clear benefit for patients, and we are excited to now market the product in Europe for use in combination with radioiodine,” said Mike Heslop, senior vice president and general manager of Genzyme’s endocrine business. “This approval represents significant progress in our program to increase the potential clinical applications for Thyrogen.”
Approximately 35,000 ablation procedures are performed annually in the US and Europe combined, and Thyrogen has the potential to be used by up to 80% of these patients.
Genzyme established a commercial oncology franchise last year to address comprehensive cancer care from diagnosis to therapeutics to follow-up monitoring. Thyrogen is an important adjunct to thyroid cancer management because it can help lead to earlier detection of recurrence, which in turn may prevent deaths from this highly treatable disease.
Thyrogen is currently indicated in the US for use as a diagnostic tool in the management of patients being tested for the recurrence of well-differentiated thyroid cancer.