Cellectar Biosciences(US:CLRB) Globenewswire·2025-10-06 11:00Core Viewpoint - Cellectar Biosciences is preparing to submit a Conditional Marketing Authorization (CMA) application for iopofosine I 131 as a treatment for refractory Waldenstrom macroglobulinemia (WM), with potential European approval and commercial launch expected in 2027 [1][4]. Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing drugs for cancer treatment, utilizing its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform [14][15]. Product Details - Iopofosine I 131 is a novel cancer-targeting agent designed for post-BTKi refractory WM patients, having received PRIME designation from the EMA for patients who have undergone at least two prior lines of therapy [2][11]. - The drug has demonstrated an overall response rate (ORR) of 83.6% and a major response rate (MRR) of 58.2% in the CLOVER WaM Phase 2 study [4][6]. Regulatory Pathway - The decision to file for CMA follows advice from the Scientific Advice Working Party (SAWP) of the EMA, which indicated that the data supports the eligibility for CMA submission for the specified patient population [3][8]. - CMA allows for earlier access to medicines addressing unmet medical needs, permitting approval based on less comprehensive clinical data [8]. Market Opportunity - There is a significant unmet medical need for WM treatment in Europe, affecting an estimated 35,000 to 45,000 patients [3][12]. - The company believes that iopofosine I 131 presents a substantial market opportunity due to its compelling patient outcomes and regulatory designations [5][12]. Future Plans - The company plans to pursue worldwide approval, including a New Drug Application (NDA) with the U.S. FDA under an accelerated approval pathway, contingent upon obtaining additional funding for a confirmatory study [4][6]. - The U.S. NDA will be supported by data from the Phase 2b CLOVER WaM clinical trial, which includes FDA-requested follow-up results [6][7].