FDA Approves Vandetanib for Metastatic Medullary Thyroid Cancer

The FDA has approved vandetanib for the treatment of unresectable, late-stage, metastatic medullary thyroid cancer (MTC). Vandetanib, a kinase inhibitor with orphan drug status marketed by AstraZeneca Pharmaceuticals LP, prevents MTC from expanding by blocking the RET protein and blood vessels that feed tumors.

Of the nearly 45,000 cases of thyroid cancer diagnosed each year in the United States, only about 1400 of those are MTC. The 5-year survival rate for MTC is approximately 83%, which is lower than the 5-year survival rate for papillary and follicular thyroid cancer (ie, approximately 90% to 94%). Vandetanib is also being studied for use against papillary thyroid cancer.

In a press release, Howard Hutchinson, Chief Medical Officer of AstraZeneca, said that vandetanib is the only drug that has been approved by the FDA specifically for patients with advanced MTC. The prescription for Vandetanib will be dispensed by Biologics Inc and manufactured by AstraZeneca.

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Vandetanib was approved by the FDA based on the results of a phase III double-blind study of 331 patients with unresectable locally advanced or metatastic MTC. Patients who took vandetanib 300 mg (n = 231) compared with placebo (n = 100) had a longer period of progression-free survival (22.6 months vs 16.4 months).