Genzyme, the Cambridge biotechnology company now owned by French drug maker Sanofi SA, said that a drug used in treating thyroid cancer has been approved for wider use in Europe.
The drug is Thyrogen, and it has been approved for use in the management of patients with thyroid cancer in the United States since 1998. It has also been approved for use in Europe.
In Friday’s press release, Genzyme said it has received European Commission approval of a product label expansion for the use of Thyrogen.
In many cases, people with thyroid cancer have their thyroids removed. Four to six weeks after that surgery, there is often a second medical procedure to ensure that all cancerous tissue has been removed. That second procedure is called radioactive remnant ablation, or RRA, and it requires the use of radio-iodine to help doctors locate cancerous tissue.
After their thyroids have been removed, patients must take thyroid replacement hormones or risk hypothyroidism, a condition that can make a person lethargic, forgetful, and prone to weight gain. In the past, hormone replacement therapy could not be started until after the RRA procedure. Thyrogen enables many patients to begin hormone replacement therapy after the first surgery to remove the thyroid, which then reduces their risk of getting hypothroidism.
Over the years, some medical professionals have become convinced that many RRA procedures can performed successfully by using smaller amounts of radio-iodine. Previously, Thyrogen had been approved for use only in procedures that used 100 microcuries of radio-iodine. (The microcurie is a commonly used measure of radiation.)
The approval by European regulators allows Thyrogen to be used in concert with RRA procedures in which the amount of radio-iodine used is anywhere from 30 to 100 microcuries.
In other words, doctors in Europe now have more options when using Thyrogen for ablation.
Genzyme said it is currently in dialogue with the Food and Drug Administration to achieve a modified label for low-dose RRA use of Thyrogen in the United States.