AstraZeneca has received approval from the European Commission for its thyroid cancer pill Caprelsa.
The drug, an oral kinase inhibitor, first impressed the European Medicines Agency's Committee for Medicinal Products for Human Use three months ago, and Caprelsa is now the first approved treatment for advanced medullary thyroid cancer (MTC).
The approval is based on a Phase III trial that showed a 54% reduction in the risk of disease progression amongst the 331 patients involved in comparison to placebo.
The road to approval for Caprelsa, once known as Zactima, has not been a simple one however. Once touted as a potential blockbuster for advanced non-small cell lung cancer, AZ was forced to withdraw marketing applications in October 2009 following the drug demonstrating no overall survival advantage in clinical trials.
AstraZeneca Caprelsa medical science director James Vasselli confirmed the company's delight at the approval, citing that the drug offers new treatment option for patients suffering from the disease.
"Advanced medullary thyroid cancer is a rare disease with a poor prognosis and clinical outcomes for patients with advanced MTD have not changed substantially in the past 20 years," said Vasselli.
Caption: AstraZeneca's headquarters, located in London, UK. Credit: AstraZeneca
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