Cellectar Biosciences Achieves FDA Breakthrough Therapy Designation For Novel Cancer Treatment

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Cellectar Biosciences, Inc. (NASDAQ:CLRB), a pioneering late-stage clinical biopharmaceutical company, has recently been granted a Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) for its innovative cancer treatment, iopofosine I 131. This designation marks a significant milestone in the treatment of relapsed/refractory Waldenstrom macroglobulinemia (r/r WM), a subtype of lymphoplasmacytic lymphoma that remains incurable with current therapies.

The FDA’s decision was influenced by the compelling data from the CLOVER WaM Phase 2 study, which demonstrated an impressive overall response rate (ORR) of 83.6%. This study not only surpassed the primary endpoint of a 20% major response rate (MRR) but also highlighted the potential of iopofosine I 131 to significantly improve treatment outcomes over existing therapies.

James Caruso, president and chief executive officer of Cellectar, expressed optimism about the designation, noting that it underscores the potential of iopofosine I 131 to address a substantial unmet medical need in this life-threatening cancer. The treatment utilizes a phospholipid ether as a radioconjugate monotherapy, targeting cancer cells with precision, which could lead to fewer off-target effects and improved patient outcomes.

The Breakthrough Therapy Designation, iopofosine I 131 has received several other expedited review designations both in the United States and Europe, including 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.

Cellectar’s proactive approach extends beyond the US borders, as it has also submitted a comprehensive data package to the EMA. This submission includes extensive supportive preclinical, regulatory and manufacturing data, alongside safety and efficacy data from the CLOVER WaM Phase 2b clinical trial.

Cellectar Biosciences is committed to leveraging its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop next-generation cancer treatments. The company’s pipeline includes multiple promising projects aimed at various cancer types, including iopofosine I 131 for multiple myeloma and central nervous system lymphoma and other targeted therapies for solid tumors such as pancreatic, triple-negative breast, lung and colorectal cancers.

This recent FDA designation not only highlights the innovative approach of Cellectar in cancer therapy but also promises to bring new hope to patients battling Waldenstrom macroglobulinemia. As Cellectar continues to advance its clinical programs and explore potential partnerships, the healthcare community watches closely, anticipating the broader implications of this breakthrough on the future of cancer treatment.

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