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.
Caruso notes Cellectar’s therapy has recently shown “encouraging results” in the treatment of advanced multiple myeloma, and expects more results to arise from ongoing clinical trials before the end of the year. Read the full story here.