Cellectar Biosciences(US:CLRB)2024-05-14 17:07Market Overview - The U.S. Waldenstrom's Macroglobulinemia (WM) market is valued at approximately $2.1 billion[18] - The Relapsed/Refractory (R/R) market within WM is currently valued at around $1.05 billion[18] - Approximately 50% of patients in the 3rd line or greater setting have been retreated after prior exposure to the same therapy[20] - The 3rd line + market could grow to approximately 5,700 patients[11] Iopofosine I 131 Positioning - Iopofosine demonstrates a meaningful treatment option for R/R patients due to its novel MOA, demonstrated clinical benefit, and fixed therapy[19] - Iopofosine has a 61% advantage with potential FDA approval and a major response rate[21] - Iopofosine shows a 75.6% overall response rate and 7.3% complete responses[21] Market Share & Treatment Landscape - Over 60% of the drug share across all lines of therapy is non-FDA approved[20] - BCL2 (venetoclax) inhibitor utilization is between 1-4% across all lines of treatment[20] - In the 3rd line setting, BTKi patients who received a BTKi in the 2nd line account for 52%[20] Manufacturing and Logistics - The existing supply maximum is approximately 1,000 units per week, with additional sites potentially increasing this by approximately 50%[2] - The novel formulation provides a 17-day shelf-life[2] - The company aims to provide US sites with drug product within 24 hours[2]