AstraZeneca files thyroid cancer pill in both United States and European Union

AN AstraZeneca pill that disappointed last year in treating lung cancer has now been submitted for regulatory approval as a treatment for thyroid cancer, offering the drugmaker a smaller sales opportunity.

AstraZeneca said the US Food and Drug Administration (FDA) and the European Medicines Agency had accepted submissions for vandetanib. The FDA also granted priority review status, meaning the agency will make a decision in early 2011.

The company had previously said it planned to file in the third quarter of 2010, after presenting promising clinical results.

Patients with advanced medullary thyroid cancer (MTC) given vandetanib experienced a 54 per cent reduction in the rate at which their disease progressed compared to those taking a placebo, results of a late-stage study showed.

The medicine had once been seen as a potential blockbuster but it suffered a big setback after failing to show an overall survival benefit in lung cancer, leading AstraZeneca to pull regulatory filings in that disease last October.