The European Commission has granted Cellectar Biosciences orphan drug designation and 10 years of European market exclusivity for CLR 131 in Waldenstrom’s Macroglobulinemia (WM), the company announced today.

“Receipt of European orphan drug designation provides Cellectar with significant regulatory benefits and further validates the clinical potential of CLR 131 in WM,” Cellectar Biosciences President James Caruso said in a statement. “In addition, the European orphan designation complements our U.S. orphan drug and U.S. fast track designations previously granted by the FDA.”

According to a release, European orphan designation is given to medicinal products that are deemed to provide a clinically relevant advantage or make a major contribution to patients’ care, compared with existing methods to treat the condition; are intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating and where the prevalence of the condition in the EU is less than 5 in 10,000 persons.

CLR 131 was previously granted orphan drug designation for the treatment of lymphoplasmacytic lymphoma, multiple myeloma, neuroblastoma, rhabdomyosarcoma, osteosarcoma and Ewing’s sarcoma.