Overview
Eribulin is a microtubule inhibitor indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Eribulin was isolated from the marine sponge Halichondria okadai. Eribulin is also being investigated for use in the treatment of advanced solid tumors .
Background
Eribulin is a microtubule inhibitor indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Eribulin was isolated from the marine sponge Halichondria okadai. Eribulin is also being investigated for use in the treatment of advanced solid tumors .
Indication
For the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic cancer.
Associated Conditions
- Metastatic Liposarcoma
- Refractory, metastatic Breast cancer
- Unresectable Liposarcoma
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/06 | Phase 1 | Recruiting | |||
2025/05/04 | Phase 1 | Not yet recruiting | |||
2025/04/24 | Phase 1 | Not yet recruiting | |||
2024/12/12 | Phase 2 | Not yet recruiting | |||
2024/09/19 | Phase 1 | Withdrawn | |||
2024/08/06 | Phase 2 | Not yet recruiting | Wang Jiayu | ||
2024/07/25 | Phase 3 | Not yet recruiting | |||
2024/06/07 | Phase 2 | Recruiting | |||
2024/05/30 | Phase 3 | Recruiting | |||
2024/04/29 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Eisai Inc. | 62856-389 | INTRAVENOUS | 0.5 mg in 1 mL | 11/17/2023 | |
| Baxter Healthcare Company | 10019-080 | INTRAVENOUS | 0.5 mg in 1 mL | 10/1/2024 | |
| BSP Pharmaceuticals SpA | 43624-002 | INTRAVENOUS | 0.5 mg in 1 mL | 11/22/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 6/27/2024 | ||
Authorised | 6/27/2024 | ||
Authorised | 3/17/2011 | ||
Authorised | 2/9/2024 | ||
Authorised | 6/27/2024 | ||
Authorised | 6/27/2024 | ||
Authorised | 2/9/2024 | ||
Authorised | 3/17/2011 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Halaven Solution for Injection 0.5mg/mL | SIN13917P | INJECTION, SOLUTION | 1.0 mg/vial | 2/9/2011 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Eribulin Mesilate Injection | 国药准字H20253131 | 化学药品 | 注射剂 | 1/14/2025 | |
| Eribulin Mesilate Injection | 国药准字H20233223 | 化学药品 | 注射剂 | 2/28/2023 | |
| Eribulin Mesilate Injection | 国药准字H20249579 | 化学药品 | 注射剂 | 12/1/2024 | |
| Eribulin Mesilate Injection | 国药准字H20249690 | 化学药品 | 注射剂 | 12/6/2024 | |
| Eribulin Mesilate Injection | 国药准字HJ20190042 | 化学药品 | 注射剂 | 2/7/2024 |
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 |
|---|---|---|---|---|---|
| ERIBULIN DR. REDDY'S eribulin mesilate 1 mg/2 mL solution for injection vial | 390346 | Medicine | A | 10/22/2024 | |
| HALAVEN eribulin mesilate 1 mg/2 mL solution for injection glass vial | 187136 | Medicine | A | 9/4/2012 | |
| ERIBULIN-RZ eribulin mesilate 1 mg/2 ml solution for injection vial | 390343 | Medicine | A | 10/22/2024 | |
| ERIBULIN-DRLA eribulin mesilate 1 mg/2 mL solution for injection vial | 390344 | Medicine | A | 10/22/2024 | |
| REDDY'S-ERIBULIN eribulin mesilate 1 mg/2 mL solution for injection vial | 390345 | Medicine | A | 10/22/2024 |