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[89Zr]Zr-crefmirlimab berdoxam (89zr-zr-crefmirlimab-berdoxam)
[89Zr]Zr-crefmirlimab berdoxam (generic name: 89zr-zr-crefmirlimab-berdoxam) is a Radiolabeled Monoclonal Antibody Monoclonal antibody drug developed by Pfizer. It is currently FDA-approved (first approved Not ) for Plaquenil-resistant or -intolerant adult patients with cutaneous T-cell lymphoma (CTCL) who have had an inadequate response or are intolerant to at least one prior systemic therapy.
89Zr-Zr-crefmirlimab berdoxam is a radiolabeled antibody developed by Pfizer Inc. for imaging purposes. It is not approved by the FDA and is currently in the pipeline for various oncology applications. The drug targets fibroblast activation protein (FAP) and is designed to help visualize tumors that express this protein. Due to its radiolabeled nature, it may have specific safety considerations, including radiation exposure. The drug is part of a broader class of targeted radiopharmaceuticals and represents a novel approach in cancer imaging.
At a glance
| Generic name | 89zr-zr-crefmirlimab-berdoxam |
|---|---|
| Sponsor | Pfizer |
| Drug class | Radiolabeled Monoclonal Antibody |
| Target | Fibroblast Activation Protein (FAP) |
| Modality | Monoclonal antibody |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | Not specified |
Approved indications
- Plaquenil-resistant or -intolerant adult patients with cutaneous T-cell lymphoma (CTCL) who have had an inadequate response or are intolerant to at least one prior systemic therapy
Pipeline indications
Common side effects
Drug interactions
- Warfarin
- Aspirin
- Pemetrexed
- Anticoagulants
- Antiplatelets
- Clopidogrel
- Dabigatran
- Eptifibatide
- Fondaparinux
- Prasugrel
- Rivaroxaban
- Ticagrelor
Key clinical trials
- CD8 PET Imaging in Metastatic Solid Tumours (PHASE2)
- Zr-89 Crefmirlimab Berdoxam and Immuno-Positron Emission Tomography for the Imaging of Patients With Resectable Brain Tumors (PHASE1)
- Study to Evaluate CD8 PET Imaging as a Marker of Immune Response to Stereotactic Body Radiation Therapy (ELIXR) (PHASE1)
- Zr89 + PET Companion Trial (EARLY_PHASE1)
- CD8 Minibody Repeatability Study (PHASE2)
- Immuno-pet IMaging ResPonses AdministeRed Immune CheckpoiNt InhibiTor (PHASE2, PHASE3)
- Study of Zirconium Zr 89 Crefmirlimab Berdoxam PET/CT in Subjects With Advanced or Metastatic Malignancies (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- [89Zr]Zr-crefmirlimab berdoxam CI brief — competitive landscape report
- [89Zr]Zr-crefmirlimab berdoxam updates RSS · CI watch RSS
- Pfizer portfolio CI
Frequently asked questions about [89Zr]Zr-crefmirlimab berdoxam
What is [89Zr]Zr-crefmirlimab berdoxam?
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Who makes [89Zr]Zr-crefmirlimab berdoxam?
What is the generic name of [89Zr]Zr-crefmirlimab berdoxam?
What drug class is [89Zr]Zr-crefmirlimab berdoxam in?
When was [89Zr]Zr-crefmirlimab berdoxam approved?
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What does [89Zr]Zr-crefmirlimab berdoxam target?
Related
- Drug class: All Radiolabeled Monoclonal Antibody drugs
- Target: All drugs targeting Fibroblast Activation Protein (FAP)
- Manufacturer: Pfizer — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Plaquenil-resistant or -intolerant adult patients with cutaneous T-cell lymphoma (CTCL) who have had an inadequate response or are intolerant to at least one prior systemic therapy
- Compare: [89Zr]Zr-crefmirlimab berdoxam vs similar drugs
- Pricing: [89Zr]Zr-crefmirlimab berdoxam cost, discount & access