Cellectar BioSciences Presents Phase 3 Trial Plan for Iopofosine in Waldenström Macroglobulinemia
Bitget2026/10/29 19:42- Cellectar BioSciences plans to submit an FDA accelerated approval application for iopofosine I 131 in Waldenström macroglobulinemia in the first half of 2027.
- Potential US accelerated approval is targeted for the second half of 2027.
- The Phase 3 confirmatory trial targets approximately 200 patients, with first enrollment projected for the first quarter of 2027.
- Phase 2b data showed an 83.6% overall response rate; median response duration reached 17.8 months.
- Estimated total Phase 3 trial cost is $42 million, with progression-free survival data expected 24–30 months following first patient enrollment.
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