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Fudr (FLOXURIDINE)
Floxuridine, also known as FUDR, is a small molecule antimetabolite drug that targets thymidylate synthase. It was originally developed and is currently owned by Hospira. FUDR is FDA-approved for treating malignant neoplasms of the liver and primary malignant neoplasms of the gastrointestinal tract. The drug is off-patent and has multiple generic manufacturers. Key safety considerations include its potential for severe gastrointestinal and hematological toxicity.
At a glance
| Generic name | FLOXURIDINE |
|---|---|
| Sponsor | Hospira |
| Drug class | Antimetabolite [EPC] |
| Target | Thymidylate synthase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1970 |
Approved indications
- Malignant neoplasm of liver
- Primary malignant neoplasm of gastrointestinal tract
Boxed warnings
- WARNING It is recommended that floxuridine be given only by or under the supervision of a qualified physician who is experienced in cancer chemotherapy and intra-arterial drug therapy and is well versed in the use of potent antimetabolites. Because of the possibility of severe toxic reactions, all patients should be hospitalized for initiation of the first course of therapy.
Common side effects
- photosensitivity
- pruritic maculopapular rash
- increased pigmentation of the skin
- vein pigmentation
- lacrimal duct stenosis
- visual changes
- lacrimation
- photophobia
- disorientation
- confusion
- euphoria
- epistaxis
Drug interactions
- CYP2C9 Substrates
Key clinical trials
- Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial (PHASE3)
- PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma (PHASE2)
- A Study of the Use of the Medtronic Pump and Codman Catheter to Give Chemotherapy to Patients With Colorectal Carcinoma or Cholangiocarcinoma (PHASE2)
- ICARuS Post-operative Intraperitoneal Chemotherapy (EPIC) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) After Optimal Cytoreductive Surgery (CRS) for Neoplasms of the Appendix, Colon or Rectum With Isolated Peritoneal Metastasis (PHASE2)
- Camrelizumab Plus Apatinib in Patients With High-risk Gestational Trophoblastic Neoplasia (PHASE2)
- Study of Safety/Feasibility of a Hybrid Model of Tertiary and Community Delivery of Hepatic Artery Infusion Chemotherapy (PHASE2)
- HAI-Floxuridine, or SIRT, Combined With Gemox For Patients With Intra-Hepatic Cholangiocarcinoma Not Amenable to Resection (TOMCAT) (PHASE2)
- Hepatic Artery Infusion Pump Chemotherapy With Floxuridine and Dexamethasone in Combination With Systemic Chemotherapy for Patients With Colorectal Cancer Metastatic to the Liver (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:
- Fudr CI brief — competitive landscape report
- Fudr updates RSS · CI watch RSS