A drug shortage has been solved. Genzyme is now able to supply its thyroid cancer treatment, Thyrogen, even as it moves further into thyroid cancer treatment with a new biomarker that helps doctors determine the need for surgery.
For about three years, supplies of Genzyme's Thyrogen have been spotty. But the biotech unit of Sanofi ($SNY) says it is now producing enough of the drug to meet the needs of all patients. "We are grateful to the thyroid cancer treatment community for its ongoing patience and partnership," Alicia Secor, Genzyme's vice president and general manager of endocrinology, said in a statement.
A Genzyme spokeswoman explained in an email that the drug went onto shortage lists as Genzyme worked through manufacturing problems after a virus was found at the Boston-area plant where the drug was filled and finished. A couple of other drugs, including Fabrazyme, Genzyme's treatment for the rare Fabry disease, were also interrupted. Genzyme began manufacturing Thyrogen at its new Framingham, MA, plant when the FDA signed off on it earlier this year. Fill/finish is being handled by Hospira ($HSP), she said.
Genzyme resolved the supply problem even as it makes further inroads into thyroid cancer treatment. In January, it hooked up with Veracyte to promote the molecular diagnostics company's gene expression test Afirma. The test uses genetic biomarkers to resolve inconclusive thyroid nodule results and lower the chances of unnecessary surgery.
According to Veracyte, U.S. doctors are taking about 450,000 fine needle aspiration (FNA) samples a year. While minimally invasive, up to 30% of the results are inconclusive and--following surgery--70% to 80% of those patients turn out to have benign nodules. The partners said recently that Memorial Sloan-Kettering Cancer Center has begun using the test.
- here's the Genzyme release
- and the Veracyte release
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