Cellectar Biosciences Plans Mid-2027 NDA Submission for Iopofosine I 131 Under FDA Accelerated Approval

Cellectar Biosciences is advancing toward a mid-2027 NDA submission for iopofosine I 131 in relapsed/refractory Waldenström macroglobulinemia under the FDA Accelerated Approval Program, with site activation now underway for the required confirmatory Phase 3 trial. For regulatory affairs leads and QA directors tracking radiopharmaceutical development timelines, the parallel-track structure, confirmatory trial initiation alongside NDA preparation, reflects the operational complexity accelerated approval pathways impose on manufacturing and clinical operations simultaneously.

The confirmatory study is a randomized, controlled comparator trial targeting approximately 100 WM patients, with sites expected to open in the coming months and first patient dosing projected for early 2027. The compressed timeline between site activation and submission means CMC documentation, sterility assurance protocols, and 21 CFR Part 211 compliance for the iodine-131 radiopharmaceutical must mature concurrently with enrollment ramp-up, a coordination challenge that plant heads overseeing radiopharmaceutical manufacturing suites will recognize immediately.

Supporting the regulatory case, Cellectar presented Phase 2b CLOVER WaM data at the ASCO 2026 Annual Meeting. Among 24 evaluable patients treated immediately post-BTK inhibitor therapy, the study reported a 100% clinical benefit rate, 87.5% overall response rate, and a 79.2% major response rate. Median duration of response reached 16 months, with 20% of patients exceeding 30 months. Cytopenias were the only Grade 3 or greater adverse event, indicating a manageable toxicity profile relevant to benefit-risk documentation in the NDA package.

Separately, Cellectar initiated enrollment and dosed first patients in a Phase 1b trial of CLR 125 in triple-negative breast cancer, extending the company's phospholipid drug conjugate platform beyond the WM indication. Phase 1 data were also published in the peer-reviewed journal Cancers during the quarter, adding to the evidentiary base for the PDC mechanism across tumor types.

The mid-2027 NDA submission target sets a measurable checkpoint against which site activation rates, manufacturing readiness, and confirmatory trial enrollment velocity will all be assessed in the quarters ahead.

Source: Cellectar Biosciences, Inc. via GlobeNewswire, August 13, 2026. Company webcast and conference call held at 8:30 AM ET on the same date.