AstraZeneca has submitted vandetanib for the treatment of thyroid cancer to regulators on both sides of the Atlantic, having pulled a filing for lung cancer last year.
Now the US Food and Drug Administration and the European Medicines Agency have accepted submissions for vandetanib and the former regulator has also granted the drug priority review status as a treatment for advanced medullary thyroid cancer (MTC). The FDA has set a Prescription Drug User Fee Act action date of January 7 next year.
The submissions are based on the ZETA Phase III study that randomised 331 patients with advanced MTC to oral once-daily vandetanib 300mg or placebo. The results showed that treatment with the AstraZeneca drug significantly extended progression-free survival and demonstrated a 54% reduction in the rate of progression compared to placebo.
Vandetanib, then known as Zactima, was previously studied as a treatment for advanced non-small cell lung cancer in combination with chemotherapy but AstraZeneca withdrew an application to the FDA and EMA in October 2009 after an updated analysis demonstrated no overall survival advantage.
The Anglo-Swedish drugmaker had hoped that vandetanib would be a blockbuster but going for the thyroid cancer indication is unlikely to bring that about. The American Cancer Society estimates that more than 44,000 new cases of the disease will be diagnosed in the USA in 2010 and there are over 50,000 cases per year in Europe; MTC accounts for just 5% of all thyroid cancers.