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AstraZeneca's orphan drug wins FDA approval

AstraZeneca's medullary thyroid cancer drug vandetanib has secured approval from the US Food and Drug Administration

The US Food and Drug Administration (FDA) has approved AstraZeneca's orphan drug vandetanib for the treatment of medullary thyroid cancer that cannot be removed by surgery or that has spread to other parts of the body.

Vandetanib is a kinase inhibitor indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with non-operable, locally advanced or metastatic disease. The use of vandetanib in patients with indolent, asymptomatic or slowly progressing disease should be carefully considered because of the treatment-related risks.

Howard Hutchinson, chief medical officer at AstraZeneca, said: "Vandetanib is the only medicine to receive FDA approval specifically for use in patients with advanced medullary thyroid cancer and is the first treatment that AstraZeneca has developed and brought to market under orphan drug designation in the US."

The approval of vandetanib is based on the results of the ZETA study, a phase III, double-blind trial that randomised 331 patients with unresectable locally advanced or metastatic medullary thyroid cancer to vandetanib 300 mg or placebo. In the study, patients randomised to vandetanib showed a statistically significant improvement in progression-free survival, compared to those randomised to the placebo.

The most common adverse drug reactions (20 per cent) seen in the ZETA trial with vandetanib were diarrhoea (57 per cent), rash (53 per cent), acne (35 per cent), nausea (33 per cent), hypertension (33 per cent), headache (26 per cent), fatigue (24 per cent), decreased appetite (21 per cent) and abdominal pain (21 per cent).

The FDA's Oncologic Drugs Advisory Committee voted in December 201 that a post-approval clinical trial for vandetanib should be carried out if the drug was approved.

Vandetanib received priority review status from the FDA in September 2010. It is also under regulatory review in the European Union and Canada.

7th April 2011

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