AstraZeneca’s Caprelsa (vandetanib) received approval from the European Commission for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease, the company reported Tuesday. According to the drugmaker, the oral kinase inhibitor is the first authorized treatment for advanced MTC in the EU.
The approval, which followed a positive recommendation from the European Medicines Agency in November, was based on late-stage data, including from the ZETA study. The trial included 331 patients with advanced MTC that had progressed and spread to other parts of the body. Results showed a 54 percent reduction in risk of disease progression for Caprelsa compared to placebo.
The product, which analysts predict could generate sales of $128 million in 2016, garnered U.S. clearance last April. Caprelsa is also approved in Canada and under regulatory review in Russia, Switzerland, Brazil, Mexico, Argentina and Australia.