British drug maker AstraZeneca Plc (AZN,AZN.L) on Tuesday said the European Commission has granted marketing authorisation for Caprelsa (vandetanib). This is for the treatment of aggressive and symptomatic medullary thyroid cancer or MTC in patients with unresectable locally advanced or metastatic disease.
The company noted that the drug, a prescription oral kinase inhibitor treatment, is the first approved treatment for advanced MTC in Europe.
The marketing authorisation of CAPRELSA is based on data from the Phase III CAPRELSA clinical trial program, including the ZETA study.
The EU decision follows a positive opinion from the Committee for Medicinal Products for Human Use or CHMP in November last year and is applicable to all 27 Member States of the European Union.
James Vasselli, CAPRELSA Medical Science Director, said, "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. 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."
The company noted that the drug was granted orphan drug status and approved by the US Food and Drug Administration in April 2011. It is also approved in Canada and is under review in Russia, Switzerland, Brazil, Mexico, Argentina and Australia.
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