Genzyme granted label change for thyroid cancer drug Thyrogen

By Angela McDaniels

Seattle, Feb. 1 - Genzyme Corp. said the Food and Drug Administration has authorized a label modification for Thyrogen (thyrotropin alfa for injection) to reflect a new analysis of the pivotal study data that formed the basis of the product's regulatory filing and approval in 1998.

The study assessed each patient's quality of life across eight domains - including physical and social functioning, bodily pain, vitality and mental health - using the SF-36 Health Survey. The company said it has found an error in the use of the measurement tool's scoring algorithm. As a result, patients treated with Thyrogen showed statistically significant improvements in only four of the eight 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," Mike Heslop, senior vice president and general manager of Genzyme's endocrine business, said in a company news release.

"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."

The new SF-36 quality of life data submitted to FDA for the label correction also serves as the basis of a forthcoming article to be published in the March edition of the Journal of Clinical Endocrinology and Metabolism, the company said.

Thyrogen is approved in the United States for use in patients with well-differentiated thyroid cancer who have had their thyroid gland removed. These patients must take thyroid hormone suppression therapy and undergo periodic testing in order to detect a recurrence of the disease. Thyrogen allows them to remain on their thyroid hormone suppression therapy and avoid the debilitating symptoms of clinical hypothyroidism during follow-up testing.

The American Cancer Society estimates that 25,690 new cases of thyroid cancer were diagnosed in the United States last year, according to the release.

Genzyme is a biotechnology company based in Cambridge, Mass., that develops products and services for rare inherited disorders, kidney disease, orthopedics, cancer, transplant and immune diseases and diagnostic testing.

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