As expected, the European Commission has granted marketing authorisation for AstraZeneca's thyroid cancer pill Caprelsa.
The European Commission has given the green light to Caprelsa (vandetanib) for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced disease. The approval comes three months after the European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion on the oral kinase inhibitor, making it the first approved treatment for advanced MTC.
The thumbs-up is based on a Phase III trial which involved 331 patients with advanced MTC (which accounts for 5%-10% of all thyroid cancers) that has progressed and spread to other parts of the body. Use of Caprelsa showed a 54% reduction in risk of disease progression compared to placebo.
The drug was once touted as a blockbuster for advanced non-small cell lung cancer but the Anglo-Swedish drugmaker withdrew marketing applications in October 2009 for Caprelsa, then known as Zactima, as it demonstrated no overall survival advantage. James Vasselli, Caprelsa medical science director at AstraZeneca, said advanced MTC is "a rare disease with a poor prognosis and clinical outcomes…have not changed substantially in the past 20 years".
The drug, which was approved by the US Food and Drug Administration in April last year, is unlikely to be a massive earner for AstraZeneca and analysts have put peak sales forecasts at around $120-$130 million.