EU Panel Backs Caprelsa (vandetanib) for Advanced Medullary Thyroid Cancer

November 21, 2011

LONDON (Reuters) Nov 18 - European drug regulators have recommended that AstraZeneca's new thyroid cancer pill Caprelsa (vandetanib) be approved there for treatment of advanced and non-operable medullary thyroid cancer.

Vandetanib was once seen as a potential $1 billion-plus blockbuster for AstraZeneca, but suffered a major setback after failing to extend survival in patients with lung cancer.

The drug is now targeted at the niche market of patients with non-operable advanced medullary thyroid cancer (MTC), which accounts for about 4% of thyroid cancers.

U.S. drug regulators approved it for MTC in April.

AstraZeneca said the European agency came to its decision after reviewing data from phase III trials, which included a double-blind trial of 331 patients with advanced MTC that had spread to other parts of the body. Patients had 54% reduction in risk for disease progression with Caprelsa compared to placebo.

Advanced MTC has a poor prognosis and clinical outcomes for patients with this disease have not changed substantially in the past 20 years. Currently there are no approved therapies in Europe for this advanced stage of the disease.

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