Europe Approves AstraZeneca’s Caprelsa for Medullary Thyroid Cancer
AstraZeneca announced earlier today that the European Commission has granted marketing authorisation for their thyroid cancer pill, Caprelsa (vandetanib).
The approval was given for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease. The announcement comes three months after the European Medicines Agency’s Committee for Medicinal Products for Human Use delivered an encouraging opinion on the oral kinase inhibitor.
Caprelsa’s medical science director at AstraZeneca, James Vasselli, noted that “advanced Medullary Thyroid Cancer is a rare disease with a poor prognosis and clinical outcomes for patients” and that these outcomes “have not changed substantially in the past 20 years”.
“Caprelsa offers a new treatment option for these patients. It is the first advance of its kind for this devastating disease” to be approved for treatment of advanced Medullary Thyroid Cancer in Europe, Vasselli added.
The approval is based on the Phase III trial which involved 331 patients with advanced Medullary Thyroid Cancer that has progressed and spread to other parts of the body. Use of Caprelsa within the trial showed a 54% reduction in risk of disease progression compared to placebo.
Thyroid cancer affects roughly 48,000 people yearly within Europe, with a predicted mortality rate of 6,300. Around 25% of all Medullary Thyroid Cancer cases are genetic in nature, caused by a mutation in the RET proto-oncogene.
AstraZeneca’s drug uses two distinctive mechanisms of to target Medullary Thyroid Cancer – blocking the blood supply to the tumour by slowing the VEGF (vascular endothelial growth factor receptor) pathway and reducing the growth and survival of the tumour through EGFR (epidermal growth factor receptor) and RET (rearranged during transfection) pathways.
Caprelsa, which was approved by the US Food and Drug Administration (FDA) in April 2011, is unlikely to be a great earner for AstraZeneca and analysts have estimated top sales to be around $120-$130 million.