AstraZeneca's vandetanib approved for MTC

Thursday, April 7, 2011 11:35 AM

The FDA has approved AstraZeneca’s vandetanib, which is a kinase inhibitor and has no brand name yet, to treat adult patients with late-stage medullary thyroid cancer (MTC) who are ineligible for surgery and who have disease that is growing or causing symptoms. The once-daily oral treatment is the first agency-approved drug for MTC, which is estimated to represent 3%-5% of all thyroid cancer.

An FDA advisory board recommended approval of vandetanib based on data from the phase III ZETA study, which involved 331 patients with advanced MTC. Median progression-free survival was 16.4 months in the placebo arm and at least 22.6 months in the vandetanib arm.

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