The recommendation is expected to be adopted by the European Commission in early 2006.
EU orphan drug designation encourages the development of products to treat life-threatening or very serious conditions that affect not more than 5 in 10,000 persons in the European Union.
Advanced hereditary medullary thyroid cancer has a poor prognosis and there are currently very limited therapeutic options available. Neither standard chemotherapy regimens, nor radiation therapy, provide substantial benefits for patients with the disorder.
“EU orphan drug designation would offer hope for patients in Europe with medullary thyroid cancer, where treatment options are limited and the prognosis is poor,” said Dr Peter Langmuir, senior medical science director, AstraZeneca.
A phase II study evaluating the anti-tumor efficacy and safety of ZD6474 in patients with advanced hereditary medullary thyroid cancer is currently ongoing.