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news.The FDA has approved a supplemental indication for Genzyme's 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.
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The company said that the new indication allows Thyrogen 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.
The FDA approved Thyrogen for remnant ablation based on results from a pivotal clinical study which suggest that treatment with Thyrogen is similar to withdrawal from thyroid hormone in achieving ablation, and that it could significantly reduce the side effects of thyroid hormone withdrawal by allowing patients to remain on hormone replacement therapy.
Mike Heslop, senior vice president and general manager of Genzyme’s endocrine business, said: “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. This is an important milestone in our ongoing effort to expand the clinical applications of Thyrogen to improve patient care.”