CAMBRIDGE, Mass., Feb. 1 (UPI) -- Genzyme said it has been cleared to change thyroid-cancer drug Thyrogen's labeling to reflect improved quality of life.
The company said the Food and Drug Administration OK'd the change based on a re-analysis of 1998 data that Genzyme submitted to the agency seeking Thyrogen's approval.
Genzyme said the drug's label will be updated to reflect improvement in a patient's quality of life in eight domains, including physical and social functioning, bodily pain, vitality and mental health.
The company said that, when the quality-of-life measuring tool from the original study -- called the SF-36 Health Survey -- was first analyzed, a scoring error incorrectly showed that Thyrogen improved quality of life in only four of the eight domains.
Thyrogen is approved as a diagnostic tool in the management of patients being tested for the recurrence of well-differentiated thyroid cancer, Genzyme said. The drug allows patients to avoid the debilitating symptoms associated with thyroid hormone withdrawal, the company said.
