FDA Breakthrough: New Cancer Drug Shows 83% Response Rate in Rare Blood Cancer Treatment

Cellectar Biosciences (NASDAQ: CLRB) has received FDA Breakthrough Therapy Designation for iopofosine I 131, a potential first-in-class cancer targeting agent, for treating relapsed/refractory Waldenstrom macroglobulinemia (WM). The designation is supported by impressive Phase 2 CLOVER WaM study results, showing an 83.6% overall response rate and 58.2% major response rate, significantly exceeding the primary endpoint target of 20% MRR. The drug has already secured FDA Fast Track and Orphan Drug Designations, along with EMA Orphan Drug and PRIME Designations. Cellectar has submitted data to the EMA for potential fast-track, conditional marketing authorization, with a response expected in late July 2025. This development represents a significant advancement for WM patients, as current treatment options are limited and the condition remains incurable.

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