Vandetanib (Zactima) received full approval from the US Food and Drug Administration (FDA) for patients with nonresectable or metastatic medullary thyroid cancer (MTC). Vandetanib was initially approved under the FDA’s orphan drug program, becoming the first medical treatment for MTC.
Approval was based on data from the phase 3 ZETA trial comparing vandetanib with placebo. Vandetanib did not improve overall survival (OS), but progression-free survival (PFS) for patients in this arm was significantly better compared with the placebo group (22.6 mo vs 16.4 mo, respectively; P < .0001), resulting in a 65% reduction in risk of disease progression. Common adverse effects include diarrhea, rash, acne, nausea, hypertension, headache, fatigue, decreased appetite, and abdominal pain.
Vandetanib’s label features a black-box warning about the risks of treatment-related QT prolongation, torsades de points, and sudden death, and notes that the drug’s 19-day half-life could delay resolution of adverse reactions. To distribute vandetanib, prescribers and pharmacies must be certified with AstraZeneca’s Risk Evaluation and Mitigation Strategies program.
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