Overview
Vinorelbine is an anti-mitotic chemotherapy drug that is used in the treatment of several types of malignancies, including breast cancer and non-small cell lung cancer (NSCLC) . It was initially approved in the USA in 1990's for the treatment of NSCLC . It is a third-generation vinca alkaloid. The introduction of third-generation drugs (vinorelbine, gemcitabine, taxanes) in platinum combination improved survival of patients with advanced NSCLC, with very similar results from the various drugs. Treatment toxicities are considerable in the combination treatment setting . A study was done on the clearance rate of vinorelbine on individuals with various single polymorphonuclear mutations. It was found that there was 4.3-fold variation in vinorelbine clearance across the cohort, suggesting a strong influence of genetics on the clearance of this drug .
Background
Vinorelbine is an anti-mitotic chemotherapy drug that is used in the treatment of several types of malignancies, including breast cancer and non-small cell lung cancer (NSCLC) . It was initially approved in the USA in 1990's for the treatment of NSCLC . It is a third-generation vinca alkaloid. The introduction of third-generation drugs (vinorelbine, gemcitabine, taxanes) in platinum combination improved survival of patients with advanced NSCLC, with very similar results from the various drugs. Treatment toxicities are considerable in the combination treatment setting . A study was done on the clearance rate of vinorelbine on individuals with various single polymorphonuclear mutations. It was found that there was 4.3-fold variation in vinorelbine clearance across the cohort, suggesting a strong influence of genetics on the clearance of this drug .
Indication
Vinorelbine tartrate is indicated for adults in the treatment of advanced non-small cell lung cancer (NSCLC), as a single therapy or in combination with other chemotherapeutic drugs . Used in relapsed or refractory Hodgkin lymphoma, in combination with other chemotherapy agents . For the treatment of desmoid tumor or aggressive fibromatosis, in combination with methotrexate . For the treatment of recurrent or metastatic squamous cell head and neck cancer . For the treatment of recurrent ovarian cancer . For the treatment of metastatic breast cancer, in patients previously treated with anthracyline and/or taxane therapy . For the treatment of HER2-positive, trastuzumab-resistant, advanced breast cancer in patients previously treated with a taxane, in combination with trastuzumab and everolimus .
Associated Conditions
- Locally Advanced Non-Small Cell Lung Cancer
- Metastatic Breast Cancer
- Metastatic Cervical Cancer
- Metastatic Non-Small Cell Lung Cancer
- Recurrent Cervical Cancer
- Soft Tissue Sarcoma
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/15 | Phase 2 | Not yet recruiting | Michael Spinner, MD | ||
2025/06/06 | Phase 1 | Recruiting | |||
2025/06/03 | Phase 2 | Not yet recruiting | |||
2025/04/03 | Phase 3 | Not yet recruiting | |||
2025/04/03 | Phase 3 | Not yet recruiting | Intergroupe Francophone de Cancerologie Thoracique | ||
2025/03/04 | Not Applicable | Not yet recruiting | QIAO LI | ||
2024/11/18 | Phase 2 | Not yet recruiting | Peking University Shenzhen Hospital | ||
2024/10/09 | Phase 3 | Recruiting | |||
2024/08/29 | Not Applicable | Not yet recruiting | |||
2024/08/21 | Phase 3 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Actavis Pharma, Inc. | 45963-607 | INTRAVENOUS | 10 mg in 1 mL | 5/31/2022 | |
| Sagent Pharmaceuticals | 25021-204 | INTRAVENOUS | 10 mg in 1 mL | 4/3/2020 |
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 |
|---|---|---|---|---|---|
| NAVELBINE SOFT CAPSULE 30 mg | SIN12547P | CAPSULE, LIQUID FILLED | 30 mg | 5/22/2004 | |
| NAVELBINE INJECTION 10 mg/ml | SIN06778P | INJECTION | 10 mg/ml | 1/21/1992 | |
| VINORELBINE ALVOGEN SOFT CAPSULES 20MG | SIN16174P | CAPSULE, LIQUID FILLED | 20.00 mg | 4/28/2021 | |
| VINORELBINE ALVOGEN SOFT CAPSULES 30MG | SIN16173P | CAPSULE, LIQUID FILLED | 30.00 mg | 4/28/2021 | |
| NAVELBINE SOFT CAPSULE 20 mg | SIN12546P | CAPSULE, LIQUID FILLED | 20 mg | 5/22/2004 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Vinorelbine Tartrate Soft Capsule | 国药准字HJ20140658 | 化学药品 | 胶囊剂 | 12/26/2023 | |
| Vinorelbine Tartrate Soft Capsule | 国药准字HJ20140657 | 化学药品 | 胶囊剂 | 12/20/2023 | |
| Vinorelbine Tartrate Soft Capsule | 国药准字H20233075 | 化学药品 | 胶囊剂 | 1/19/2023 | |
| Vinorelbine Tartrate Soft Capsule | 国药准字H20061234 | 化学药品 | 胶囊剂 | 2/19/2021 | |
| Vinorelbine Tartrate for Injection | 国药准字H20060612 | 化学药品 | 注射剂 | 7/19/2024 | |
| Vinorelbine Tartrate for Injection | 国药准字H20050336 | 化学药品 | 注射剂 | 6/30/2020 | |
| Vinorelbine Tartrate for Injection | 国药准字H20050198 | 化学药品 | 注射剂 | 4/10/2020 | |
| Vinorelbine Tartrate for Injection | 国药准字H20050545 | 化学药品 | 注射剂 | 2/19/2020 | |
| Vinorelbine Tartrate for Injection | 国药准字H20040477 | 化学药品 | 注射剂 | 7/18/2024 | |
| Vinorelbine Tartrate for Injection | 国药准字H20041246 | 化学药品 | 注射剂 | 8/23/2023 |
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 |
|---|---|---|---|---|---|
| Hospira VINORELBINE 10 mg/mL sterile concentrate 50 mg/5 mL vial | 152446 | Medicine | A | 5/21/2008 | |
| Vinorelbine LU vinorelbine (as tartrate) 30 mg soft capsules blister pack | 381475 | Medicine | A | 2/14/2023 | |
| VINORELBINE PIERRE FABRE vinorelbine 30mg (as tartrate) capsule blister pack | 99559 | Medicine | A | 5/31/2005 | |
| VINORELBINE PIERRE FABRE vinorelbine 50mg/5mL (as tartrate) injection vial | 74665 | Medicine | A | 8/4/2000 | |
| Hospira Vinorelbine 10 mg/1 mL Sterile Concentrate Vial | 152387 | Medicine | A | 5/15/2008 | |
| Vinorelbine Lrx vinorelbine (as tartrate) 30 mg soft capsules blister pack | 381474 | Medicine | A | 2/14/2023 | |
| Vinorelbine LU vinorelbine (as tartrate) 80 mg soft capsules blister pack | 381478 | Medicine | A | 2/14/2023 | |
| NAVELBINE ORAL vinorelbine 20mg (as tartrate) capsule blister pack | 99498 | Medicine | A | 5/31/2005 | |
| Hospira Vinorelbine Tartrate10 mg/1 mL Injection Vial | 152084 | Medicine | A | 5/5/2008 | |
| VINORELBINE AG vinorelbine (as tartrate) 50 mg/5 mL concentrated injection vial | 177544 | Medicine | A | 1/18/2012 |