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FDA expands thyroid drug use
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Today, the FDA announced revised prescribing information for thyrotropin alfa, an injectable drug given prior to radioactive iodine treatment for thyroid cancer.
Injectable thyrotropin alfa (Thyrogen, Genzyme) was recommended for prescription for patients receiving 100 mCi of radioactive iodine (RAI) treatment, but has been expanded to include patients given doses between 30 mCi and 100 mCi. The revised prescribing information follows two studies published in the New England Journal of Medicine in May 2012 comparing ablation outcomes among patients who received recombinant human thyrotropin with patients who underwent thyroid hormone withdrawal at both low and high doses of RAI, according to a company press release. Those who received thyrotropic alfa were less likely to have hypothyroid symptoms.
Bryan Haugen
The drug is given before RAI to increase uptake of the radiotracer and allows patients to continue to take thyroid hormone replacement while being treated for thyroid cancer.
"The incidence of thyroid cancer is rapidly increasing in the United States,” Bryan Haugen, MD, professor of medicine at the University of Colorado, and immediate past president of the American Thyroid Association, said in the press release. “Today’s FDA revision to widen the administered dose range of RAI for patients being prepared for remnant ablation with Thyrogen allows important management flexibility for physicians and treatment options for patients.”
Perspective
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R. Michael Tuttle, MD
For the first time, we understand the lowest effective dose that we can give for radioactive iodine ablation, based on two randomized prospective trials published in the New England Journal of Medicine. The trend in thyroid cancer is to use less radioactivity, and this new label allows us to treat thyroid cancer with a proven effective dose that will minimize the side effects of radioactive iodine.
It is helpful because we have a better appreciation over the past 5 to 10 years that there are dose-related side effects with radioactive iodine. This is coming at a very important time in history as we’re diagnosing more and more early-stage thyroid cancer over the last 20 years, so being able to use the lowest dose possible is even more important when we are treating relative low risk thyroid cancer.
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