Overview
An antineoplastic antimetabolite that is metabolized to fluorouracil when administered by rapid injection. Floxuridine is available as a sterile, nonpyrogenic, lyophilized powder for reconstitution. When administered by slow, continuous, intra-arterial infusion, it is converted to floxuridine monophosphate. It has been used to treat hepatic metastases of gastrointestinal adenocarcinomas and for palliation in malignant neoplasms of the liver and gastrointestinal tract.
Background
An antineoplastic antimetabolite that is metabolized to fluorouracil when administered by rapid injection. Floxuridine is available as a sterile, nonpyrogenic, lyophilized powder for reconstitution. When administered by slow, continuous, intra-arterial infusion, it is converted to floxuridine monophosphate. It has been used to treat hepatic metastases of gastrointestinal adenocarcinomas and for palliation in malignant neoplasms of the liver and gastrointestinal tract.
Indication
For palliative management of gastrointestinal adenocarcinoma metastatic to the liver, when given by continuous regional intra-arterial infusion in carefully selected patients who are considered incurable by surgery or other means. Also for the palliative management of liver cancer (usually administered by hepatic intra-arterial infusion).
Associated Conditions
- Stage 4 gastrointestinal adenocarcinoma
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/03/15 | Phase 2 | Active, not recruiting | Oslo University Hospital | ||
2023/05/17 | Phase 3 | Recruiting | ECOG-ACRIN Cancer Research Group | ||
2022/03/18 | Phase 2 | Recruiting | |||
2021/05/24 | Phase 2 | Active, not recruiting | Oslo University Hospital | ||
2021/05/18 | Phase 2 | Recruiting | |||
2020/12/16 | Phase 2 | Recruiting | |||
2020/09/17 | Phase 2 | UNKNOWN | |||
2020/02/05 | Phase 2 | Active, not recruiting | |||
2019/03/15 | Phase 1 | Completed | Xiangya Hospital of Central South University | ||
2019/02/27 | Phase 2 | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Hikma Pharmaceuticals USA Inc. | 0143-9270 | INTRA-ARTERIAL | 100 mg in 1 mL | 5/15/2023 | |
| Fresenius Kabi USA, LLC | 63323-145 | INTRA-ARTERIAL | 500 mg in 5 mL | 12/31/2019 | |
| Cerona Therapeutics, Inc. | 81643-9270 | INTRA-ARTERIAL | 500 mg in 1 1 | 6/13/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Floxuridine for Injection | 国药准字H20013178 | 化学药品 | 注射剂 | 6/3/2020 | |
| Floxuridine for Injection | 国药准字H20058002 | 化学药品 | 注射剂 | 4/9/2024 | |
| Floxuridine for Injection | 国药准字H20013179 | 化学药品 | 注射剂 | 6/3/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||