Genzyme announces FDA approval of Thyrogen for thyroid cancer ablation

Our Corporate Bureau
18 December 2007

Nasdaq-listed biotechnology major Genzyme Corporation announced today that the US Food and Drug Administration (FDA) has approved a supplemental indication for Thyrogen (thyrotropin alfa for injection) to be used in combination with radioiodine to ablate, or destroy, the remaining thyroid tissue in patients who have had their cancerous thyroids removed.

Remnant ablation is a procedure that patients commonly undergo when being treated for thyroid cancer.

"This new indication extends the significant benefits of Thyrogen to patients during their initial treatment for thyroid cancer, in addition to its current use in follow-up diagnostic procedures to detect recurrence," said Mike Heslop, senior vice president and general manager of Genzyme's endocrine business.

"This is an important milestone in our ongoing effort to expand the clinical applications of Thyrogen to improve patient care," he said.

The American Cancer Society estimates that in 2007, about 33,550 new cases of thyroid cancer will be diagnosed in the United States. Approximately 90 per cent of all thyroid cancers are well-differentiated, making those patients candidates for the remnant ablation procedure.

"The development of new treatment options for thyroid cancer patients is critical, as this disease has the fastest rising incidence of all cancers among women in the US," said clinical investigator Paul Ladenson, MD, professor and director of endocrinology at the Johns Hopkins University School of Medicine.