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news.Cellectar Biosciences has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for iopofosine I 131.
The designation was based on the data from the CLOVER WaM study. Credit: Daniel Dan/Unsplash.
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The designation is granted to iopofosine I 131 for the treatment of relapsed/refractory Waldenstrom macroglobulinemia (r/r WM), a subtype of lymphoplasmacytic lymphoma currently without a cure.
WM remains an incurable disease, with limited treatment options available.
The designation was based on the data from the Phase II CLOVER WaM study, which reported an overall response rate (ORR) of 83.6% and a major response rate (MRR) of 58.2%. These results surpassed the primary endpoint target MRR of 20%.
The company’s iopofosine I 131 has also received fast track designation and orphan drug designation in the US.
Similarly, the European Medicines Agency (EMA) has granted orphan drug and PRIME designations to iopofosine I 131 for r/r WM treatment.
For regulatory approval in Europe, Cellectar has submitted a comprehensive data package to EMA that includes preclinical findings, regulatory details, manufacturing information, as well as safety and efficacy data from the CLOVER WaM Phase IIb clinical trial.
The EMA will assess whether this evidence meets criteria to consider fast-track conditional marketing authorisation approval (MAA), and the company anticipates this by late July 2025.
Cellectar president and CEO James Caruso said: “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.
“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.”
