Cellectar BioSciences presents Phase 3 trial plan for iopofosine in Waldenström macroglobulinemia
CLRB•Cellectar BioSciences plans to seek FDA accelerated approval for iopofosine I 131 in the first half of 2027, targeting potential approval in the second half. Its planned Phase 3 trial aims to enroll about 200 patients, with an estimated cost of $42 million.
1. Trial and filing plans
Cellectar BioSciences projects first enrollment in its Phase 3 confirmatory trial in the first quarter of 2027 and plans to submit an FDA accelerated approval application in the first half of that year. The company targets potential U.S. accelerated approval in the second half of 2027. The trial is expected to cost $42 million, with progression-free survival data expected 24–30 months after the first patient enrolls.
2. Phase 2b results
Phase 2b data showed an 83.6% overall response rate and a median response duration of 17.8 months.
