Genzyme gets label change for Thyrogen

US biotechnology firm Genzyme says that the Food and Drug Administration has authorized a label modification for Thyrogen (thyrotropin alfa for injection) to reflect positive patient outcomes based on a new analysis of the pivotal study data that formed the basis of the product's regulatory filing and approval in 1998.

Thyrogen is currently indicated in the USA for use as a diagnostic tool in the management of patients being tested for the recurrence of well-differentiated thyroid cancer. The product allows patients to avoid the potentially-debilitating symptoms associated with 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 pivotal trial of Thyrogen revealed that the quality of life data are shown to be in favor of the Thyrogen-treated arm in all eight domains (p<0.0001 for all) compared to the withdrawal arm of the study.