FDA Approves Thyrotropin Alfa for Use in Thyroid Cancer Ablation

January 1, 2008

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

Genzyme Corp. recently announced that the US Food and Drug Administration (FDA) has approved a supplemental indication for thyrotropin alfa for injection (Thyrogen) 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.

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

Impact on Quality of Life

"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. "The availability of Thyrogen for use in remnant ablation is a notable advance, as it permits patients to maintain a good quality of life during the course of their thyroid cancer treatment and follow-up testing."

Thyrotropin alfa was initially approved in the US in 1998 for use as a diagnostic tool in the management of patients being tested for the recurrence of well-differentiated thyroid cancer. The product helps increase the sensitivity of testing while allowing patients to avoid the potentially debilitating symptoms of thyroid hormone withdrawal.

The new indication allows thyrotropin alfa to be used in conjunction with radioiodine for the most common approach to treating thyroid cancer. This includes surgical removal of the cancerous thyroid followed by remnant ablation, which destroys any remaining thyroid tissue. This can help reduce the risk of disease recurrence and facilitate follow-up monitoring.