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Investing.com -- Shares of Cellectar Biosciences Inc (NASDAQ:CLRB) surged 63.5% following the announcement that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for its cancer treatment drug, iopofosine I 131. This designation is for the treatment of relapsed/refractory Waldenstrom macroglobulinemia (r/r WM), a dominant subtype of lymphoplasmacytic lymphoma that currently has limited treatment options.
The FDA’s Breakthrough Therapy Designation is intended to expedite the development and review of drugs that are meant to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. Cellectar’s President and CEO, James Caruso, highlighted the designation as a recognition of iopofosine I 131’s potential to substantially improve treatment for this life-threatening cancer.
Cellectar also noted the promising data from the Phase 2 CLOVER WaM study, which showed an overall response rate (ORR) of 83.6% and a major response rate (MRR) of 58.2%. These results surpassed the primary endpoint target of a 20% MRR. The study’s findings were presented at the 66th Annual American Society of Hematology Conference in December 2024, signaling a significant milestone in the drug’s clinical journey.
In addition to the FDA’s latest designation, iopofosine I 131 has previously received Fast Track and Orphan Drug Designations from the FDA and Orphan Drug and PRIME Designations from the European Medicines Agency (EMA) for the treatment of r/r WM. The EMA is currently reviewing a comprehensive data package from Cellectar, which could lead to a conditional marketing authorization approval. The company expects to receive guidance from the EMA by late July 2025 regarding a potential Medical (TASE:BLWV) Authorization Application (MAA).
Investors have responded positively to the breakthrough designation and the potential for expedited development and commercialization of iopofosine I 131. Cellectar’s advancements underscore the company’s commitment to addressing the unmet medical needs in cancer treatment and may position it favorably for potential collaborations or partnerships.
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