Genzyme Granted Label Change for Thyrogen

Monday January 30, 2006

Drug company Genzyme announced this week that the U.S. Food and Drug Administration (FDA) has approved a modification to the label for Thyrogen (thyrotropin alfa for injection), their drug used for thyroid cancer patients. The revised label will reflect positive patient outcomes based on a new analysis of the study data that formed the basis of the product's regulatory filing and approval in 1998.

Thyrogen is currently used as part of the diagnostic management of patients being tested for the recurrence of thyroid cancer. Thyrogen allows patients to avoid the potentially debilitating symptoms associated with hypothyroidism due to thyroid hormone withdrawal.

The SF-36 Health Survey is a standardized instrument assessing a patient's quality of life across eight domains, measuring both physical and mental functioning. A recent re-analysis of the SF-36 data from the trial of Thyrogen showed that the quality of life data are shown to be in favor of the Thyrogen-treated arm of the study in domains that include physical and social functioning, bodily pain, vitality and mental health. When the original regulatory filing for Thyrogen occurred, there was an error in the use of the measurement tool's scoring algorithm, and Thyrogen was shown to be statistically significant in only four domains. The label modification for Thyrogen now clearly states the positive impact of the product in all eight quality of life indicators.

"Changing the label is significant because it now underscores with quantitative data what has been seen in practice for the past several years -- that Thyrogen has a positive impact on both physical and mental functioning of thyroid cancer patients," stated Mike Heslop, senior vice president and general manager of Genzyme. "The new label details the benefit that Thyrogen provides patients in alleviating hardships associated with withdrawal from thyroid hormone. As a result, it is our hope that more patients will pursue ongoing monitoring so that any recurrence of disease can be discovered and treated quickly."

Recent data released from the U.S. National Cancer Institute shows that thyroid cancer is now ranked first among all cancers in incidence growth in both women and men. Additionally, for those patients that received successful initial treatment, recurrence rates of up to 30 percent underscore the importance of long-term, follow-up testing to foster early detection for what is considered a highly-treatable disease.

The American Cancer Society estimates that about 25,690 new cases of thyroid cancer were diagnosed in the United States last year. It is three times more common in women than in men. Most cases of thyroid cancer are discovered during a routine physical examination when a painless lump is found in the thyroid. In accordance with major guidelines for treating thyroid cancer, the majority of patients have their thyroid surgically removed and undergo radioiodine ablation which, in addition to facilitating follow-up monitoring, may reduce recurrences of thyroid cancer.

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