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Cellectar Receives Orphan Drug Designation from the European Commission for CLR 131 in Waldenstrom’s Macroglobulinemia
Benefits include 10 years of market exclusivity in the European Union FLORHAM PARK, N.J., Jan. 27, 2021 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc.
About this update from Cellectar Biosciences, Inc.
[{"type":"text","content":"Benefits include 10 years of market exclusivity in the European Union\nFLORHAM PARK, N.J., Jan. 27, 2021 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of drugs for the treatment of cancer, today announced that the European Medicines Agency has adopted a positive opinion for CLR 131 orphan designation for the treatment of Waldenstrom’s Macroglobulinemia (WM). 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 prevalence of the condition in the EU is less than 5 in 10,000 persons. “WM is an incurable disease with treatment options restricted to one approved drug and various salvage therapies. The 100% overall response rate and durability of these responses after four 15 minute infusions spread over 80 days seen to date with CLR 131, supports our belief that CLR 131 can be an important therapy for WM patients,” said James Caruso, president and CEO of Cellectar. “Receipt of European orphan drug designation provides Cellectar with significant regulatory benefits and further validates the clinical potential of CLR 131 in WM. In addition, the European orphan designation complements our U.S. orphan drug and U.S. fast track designations previously granted by the FDA.” Cellectar has initiated a pivotal trial evaluating CLR 131 in Waldenstrom’s macroglobulinemia patients that have failed or had a suboptimal response to a Bruton’s tyrosine kinase inhibitor at select US cancer centers and intends to expand the trial to additional US and international sites in the first quarter of the year. Additional information can be found at www.ClinicalTrials.gov. The European Medicines Agency (EMA) plays a central role in facilitating the development and authorization of medicines for rare diseases. Orphan designation benefits include protocol assistance, reduced EU regulatory filing fees and 10 years of European market exclusivity which protects CLR 131 from competition from similar medicines with similar indications, which cannot...