01 Oct Cancer therapy receives ‘orphan drug’ designation from European Commission
Cellectar Biosciences’ cancer therapy has received “orphan drug” designation from the European Commission for the treatment of multiple myeloma, a cancer of the body’s plasma cells.
“This designation complements our U.S. orphan drug designation and U.S. fast track designation already granted by the FDA,” said company CEO and President James Caruso.
Orphan designation in Europe is reserved for medicines that satisfy several key requirements. They must be intended for treating “life-threatening or seriously debilitating” diseases that rarely occur, with a prevalence in the European Union of less than five in 10,000. The product or treatment must also represent a “significant benefit” over existing treatments.
Along with the designation, Cellectar will qualify for reduced EU regulatory filing fees, up to 10 years of market exclusivity and other benefits.
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