FDA Breakthrough Therapy Designation granted to Iopofosine I 131 in Waldenstrom Macroglobulinemia (WM)
“The FDA’s Breakthrough Therapy Designation underscores the potential of iopofosine I 131 as it may offer substantial improvement on at least one clinically significant endpoint over available therapies to address the substantial unmet medical need in this life-threatening cancer,” said James Caruso, president and chief executive officer of Cellectar. “With robust clinical data, a favorable safety profile, expedited review designations in the United States and Europe and a compelling commercial market potential, we believe iopofosine I 131 represents an attractive candidate for potential collaborations or partners seeking impactful innovation and accelerated development pathways.”
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