Cellectar BioSciences presents Phase 3 confirmatory trial plans for iopofosine in Waldenström's macroglobulinemia
CLRB•Cellectar BioSciences plans to submit a US accelerated approval application for iopofosine I 131 in the first half of 2027, with potential approval targeted for the second half. Its planned 200-patient Phase 3 trial is expected to begin enrollment in the first quarter of 2027 and cost an estimated $42 million.
1. Trial and application plans
Cellectar BioSciences plans to submit a US accelerated approval application for iopofosine I 131 in Waldenström macroglobulinemia in the first half of 2027 and is targeting potential approval in the second half. The planned 200-patient Phase 3 confirmatory trial projects first enrollment in the first quarter of 2027 and an estimated total cost of $42 million. Phase 2b data in 55 evaluable patients showed an 83.6% overall response rate, a 61.8% major response rate, median response duration of 17.8 months and median progression-free survival of 13.5 months.
