This section highlights FDA-related milestones and regulatory updates for drugs developed by Cellectar Biosciences (CLRB).
Over the past two years, Cellectar Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
CLR and Iopofosine. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
CLR 125 - FDA Regulatory Timeline and Events
CLR 125 is a drug developed by Cellectar Biosciences for the following indication: For the treatment of relapsed TNBC.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CLR 125
- Announced Date:
- June 24, 2025
- Indication:
- For the treatment of relapsed TNBC.
Announcement
Cellectar Biosciences, announced that the company has submitted a protocol with the U.S. Food and Drug Administration (FDA) for a Phase 1b Dose Finding study of its Auger emitting radiopharmaceutical, CLR 125, for the treatment of relapsed TNBC. CLR 125 is an iodine-125 Auger-emitting drug candidate targeting solid tumors, such as triple negative breast, lung and colorectal cancers.
AI Summary
Cellectar Biosciences has submitted a protocol to the FDA for a Phase 1b dose-finding study of its Auger-emitting radiopharmaceutical, CLR 125. This innovative drug candidate uses iodine-125 to target solid tumors, specifically focusing on relapsed triple-negative breast cancer (TNBC), as well as lung and colorectal cancers. The study is designed to evaluate three different dosing regimens in patients with relapsed TNBC, including metastatic cases, aiming to determine the optimal dose for safety and effectiveness.
The study will use imaging to assess tumor uptake and involves 15 patients per dosing arm. By leveraging its phospholipid drug conjugate delivery system, CLR 125 is designed to deliver the therapeutic isotope directly to cancer cell nuclei and mitochondria, potentially enhancing its tumor-killing ability while reducing harmful side effects. This marks a significant step in developing a new treatment option for patients with challenging cancers.
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Iopofosine I-131 - FDA Regulatory Timeline and Events
Iopofosine I-131 is a drug developed by Cellectar Biosciences for the following indication: Pediatric Brain and Solid Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Iopofosine I-131
- Announced Date:
- June 11, 2025
- Indication:
- Pediatric Brain and Solid Tumors
Announcement
Cellectar Biosciences, announced initial results as of June 10, 2025, from the CLOVER-2 Phase 1 clinical trial evaluating iopofosine I 131 in relapsed/refractory pediatric high-grade glioma (pHGG) patients.
AI Summary
Cellectar Biosciences announced initial results from its CLOVER-2 Phase 1 trial evaluating iopofosine I 131 in relapsed/refractory pediatric high-grade glioma (pHGG) patients. The trial involved children with aggressive brain tumors, including diffuse midline gliomas, DIPG, and anaplastic ependymomas.
Patients who received a minimum total dose of 55 mCi experienced an average progression free survival of 5.4 months and overall survival of 8.6 months. Notably, those who received at least four infusions had longer averages of 8.1 months of progression free survival and 11.5 months of overall survival, with two patients achieving an objective response. The treatment was well tolerated, showing manageable hematologic side effects without significant cardiovascular, renal, or liver toxicities. These results provide promising evidence of iopofosine I 131’s potential as a new option for pediatric patients with limited treatment choices.
Read Announcement- Drug:
- Iopofosine I-131
- Announced Date:
- June 4, 2025
- Indication:
- Pediatric Brain and Solid Tumors
Announcement
Cellectar Biosciences, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for iopofosine I 131, a potential first-in-class, novel cancer targeting agent utilizing a phospholipid ether as a radioconjugate monotherapy, for the treatment of relapsed/refractory Waldenstrom macroglobulinemia (r/r WM).
AI Summary
Cellectar Biosciences announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to iopofosine I 131, a potential first-in-class cancer targeting agent. This novel treatment uses a unique phospholipid ether radioconjugate as a monotherapy and is aimed at treating patients with relapsed or refractory Waldenstrom macroglobulinemia (r/r WM), a subtype of lymphoplasmacytic lymphoma with few effective treatment options. The FDA’s decision is based on promising clinical data, which suggest that iopofosine I 131 could offer significant improvements in patient outcomes compared to current therapies. This designation is intended to expedite the development and review process, potentially leading to a faster path toward regulatory approval and making a meaningful treatment difference for patients with this challenging form of cancer.
Read Announcement- Drug:
- Iopofosine I-131
- Announced Date:
- March 13, 2025
- Indication:
- Pediatric Brain and Solid Tumors
Announcement
Cellectar Biosciences, provided a corporate update.
AI Summary
Cellectar Biosciences provided a corporate update focusing on important progress with its leading candidate, iopofosine I 131. The company has achieved alignment with the FDA on a regulatory pathway toward potential accelerated approval for iopofosine I 131 as a treatment for relapsed/refractory Waldenström macroglobulinemia (WM). CEO James Caruso emphasized the positive clinical data, which showed high response rates and a safe, manageable toxicity profile. This regulatory clarity has generated significant interest in potential collaborations, which may offer non-dilutive funding opportunities.
Additionally, Cellectar outlined its plans for advancing other radiotherapeutic compounds. The company has received IND clearance for an Auger-emitting radioconjugate and plans to file an IND for an alpha-emitting radioconjugate. These initiatives are expected to support Phase 1 clinical studies in triple-negative breast cancer and pancreatic cancer by mid-2025.
Read Announcement - Drug:
- Iopofosine I-131
- Announced Date:
- June 27, 2024
- Indication:
- Pediatric Brain and Solid Tumors
Announcement
Cellectar Biosciences, announced it will host an event on July 24, 2024, at 8:00 a.m., EDT, to provide a comprehensive overview of recent data from its pivotal trial of iopofosine I 131 in Waldenstrom's macroglobulinemia, the current treatment landscape, unmet needs for patients with this disease, and opportunities to improve patient outcomes.
AI Summary
Cellectar Biosciences announced it will host an event on July 24, 2024, at 8:00 a.m. EDT to discuss promising advancements in treating Waldenström’s macroglobulinemia. The company’s leaders and key investigators will review recent data from their pivotal trial of iopofosine I 131, focusing on the full results of the CLOVER WaM study. They will examine the current treatment landscape for this B-cell malignancy, emphasizing existing unmet needs as many patients do not achieve durable responses with current therapies. The discussion will cover how this novel treatment option could improve patient outcomes, especially for those with relapsed or refractory disease who have limited alternatives. This event underscores Cellectar Biosciences’ commitment to developing innovative, targeted therapies that may offer a safer, more effective approach to managing and ultimately transforming the treatment paradigm for this difficult-to-treat condition.
Read Announcement- Drug:
- Iopofosine I-131
- Announced Date:
- May 29, 2024
- Indication:
- Pediatric Brain and Solid Tumors
Announcement
Cellectar Biosciences, announced that a strategic partnership with City of Hope Cancer Center, one of the largest cancer research and treatment organizations in the United States.
AI Summary
Cellectar Biosciences announced a strategic partnership with City of Hope Cancer Center, one of the nation’s largest cancer research and treatment organizations. This collaboration focuses on expanding the clinical development of Cellectar’s lead radioconjugate asset, iopofosine I-131, for patients with mycosis fungoides—a rare type of non-Hodgkin’s lymphoma that typically affects the skin and may spread to internal organs and the blood.
The investigator-sponsored trial, led by experts at City of Hope, will evaluate the potential of iopofosine as a systemic targeted radiotherapeutic. The drug’s unique delivery platform may offer advantages over traditional external beam radiotherapy by targeting tumor cells throughout the body and reducing the chance of systemic progression. This effort aims to provide new treatment options for patients with limited therapies available and high unmet medical needs.
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