European Commission approves CAPRELSA® (vandetanib) for patients with advanced medullary thyroid cancer

AstraZeneca today announced that the European Commission has granted marketing authorisation for CAPRELSA® (vandetanib) for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease. CAPRELSA is the first approved treatment for advanced MTC in Europe.

This European Commission decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on 17 November 2011 and is applicable to all 27 Member States of the European Union.

“Advanced Medullary Thyroid Cancer is a rare disease with a poor prognosis and clinical outcomes for patients with advanced MTC have not changed substantially in the past 20 years.” said AstraZeneca’s Dr. James Vasselli, CAPRELSA Medical Science Director. “CAPRELSA offers a new treatment option for these patients. It is the first advance of its kind for this devastating disease and we are delighted CAPRELSA has been approved for use in Europe.”

CAPRELSA was granted orphan drug status and approved by the US Food and Drug Administration in April 2011. CAPRELSA is also approved in Canada and is under review in Russia, Switzerland, Brazil, Mexico, Argentina and Australia.

The marketing authorisation of CAPRELSA is based on data from the Phase III CAPRELSA clinical trial programme, including the ZETA study, a double-blind trial of 331 patients with advanced MTC that has progressed and spread to other parts of the body, which showed a 54 per cent reduction in risk of disease progression compared to placebo (hazard ratio 0.46; 95% CI, 0.31–0.69; P<0.001). Common side effects observed were diarrhoea, rash, headache, fatigue and hypertension. The incidence of protocol-defined QTc prolongation was 14%.