A Comprehensive Monograph on Thyrotropin Alfa (rhTSH): Biochemical Profile, Clinical Efficacy, and Role in the Modern Management of Differentiated Thyroid Cancer

Executive Summary

Thyrotropin alfa is a highly purified, biotech-engineered protein that functions as a recombinant form of human thyroid-stimulating hormone (rhTSH).[1] It represents a significant advancement in the management of patients with well-differentiated thyroid cancer, serving critical roles in both diagnosis and therapy following surgical removal of the thyroid gland (thyroidectomy).[4]

The core clinical utility of Thyrotropin alfa is defined by two primary indications approved by major regulatory bodies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). First, it is employed as an adjunctive diagnostic tool to enhance the sensitivity of serum thyroglobulin (Tg) testing and radioiodine imaging for the surveillance of cancer recurrence or residual disease. Second, it is used as an adjunctive treatment to stimulate thyroid remnant tissue for ablation with radioactive iodine (RAI).[7]

The principal therapeutic advantage of Thyrotropin alfa lies in its ability to achieve the necessary elevation of serum TSH levels without requiring the patient to cease thyroid hormone replacement therapy. This allows patients to remain in a euthyroid state, thereby circumventing the significant physical and psychological morbidity associated with the traditional method of thyroid hormone withdrawal (THW), which induces a state of profound iatrogenic hypothyroidism.[11]