Navelbine
(Vinorelbine)ApprovedSmall molecule
Vinorelbine is a chemotherapy drug used to treat certain types of cancer, particularly lung cancer and breast cancer, by stopping cancer cells from growing and dividing.[2] Navelbine is currently approved and in use across 23 indications[4].[1]
Navelbine is one of 486 small molecule programs targeting Anaplastic Large Cell Lymphoma. It is currently in Approved.
23
Indications
227
Total Trials
22
Active Trials
485
Competitors
1
FDA Application
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 23 indications
Competition
Competitive Landscape
706 competitors in Breast Cancer
#DrugCompanyPhaseTrials
1Navelbine
PPierre Fabre Medicament
Approved
Adenocard
AstellasPreclinical
Blenoxane
Bristol-Myers SquibbPreclinical
Methylthioninium Chloride
PProvepharm SAS
Preclinical
Vfend
PPrism Pharmaceuticals
Preclinical
Rilvegostomig
AstraZenecaPreclinical
Neoadjuvant Treatment
SShanghai Zhongshan Hospital
Preclinical
Recombinant Human Endostatin
PPeking University Third Hospital
Preclinical
Tianeptine
PfizerPreclinical
Ablavar
LLantheus Medical Imaging
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Breast Cancer81 trials
Show 78 more trials
Bevacizumab in Combination With Vinorelbine and Trastuzumab for HER2-Positive, Metastatic Breast Cancer
Completed·—·Phase 2·NCT00670982·29 enrolled
Trastuzumab in Combination With Vinorelbine or Taxane-Based Chemotherapy in Patients With Metastatic Breast Cancer
Completed·—·Phase 3·NCT00146549·250 enrolled
Vinorelbine Metronomic Plus Lapatinib for Overexpressing HER-2 Metastatic Breast Cancer
Terminated·—·Phase 2·NCT00754702·16 enrolled
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
Unknown status·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 2·NCT04681911·71 enrolled
Trastuzumab and Vinorelbine in Advanced Breast Cancer
Terminated·—·Phase 2·NCT01185509·31 enrolled
Safety and Efficacy of Toripalimab in HER2- Metastatic Breast Cancer Patients Treated With Metronomic Vinorelbine
Unknown status·—·Phase 2·NCT04389073·138 enrolled
Non-Small Cell Lung Cancer28 trials
Show 25 more trials
Efficacy and Safety of Concurrent Chemoradiotherapy With Oral Vinorelbine in Patients With Non-small Cell Lung Cancer
Active, not recruiting·—·Phase 2·NCT06540950·47 enrolled
Open-label, Multicenter, Randomized Phase II Trial of Treatment With Cisplatin and Pemetrexed or Cisplatin and Oral Vinorelbine in Chemotherapy Naïve Patients Affected by Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer With High Thymidylate Synthase Expression
Terminated·IIstituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS·Phase 2·NCT02919462·2 enrolled
Lung Cancer8 trials
Show 5 more trials
Cetuximab and Vinorelbine in Elderly Subjects With Lung Cancer
Completed·—·Phase 2·NCT00165334·53 enrolled
Lymphoma8 trials
Show 5 more trials
Study of Combination of PIGEV Before Autologous Stem Cell Transplant in Patients With Hodgkin's Lymphoma
Unknown status·—·Phase 1·NCT01884428·24 enrolled
Bendamustine, Gemcitabine and Vinorelbine (BeGEV) as Induction Therapy in Relapsed/Refractory Hodgkin's Lymphoma Patients
Unknown status·—·Phase 2·NCT01884441·59 enrolled
Vinorelbine7 trials
Effects of Granulocyte Colony-stimulating Factor (G-CSF), Trastuzumab, and Vinorelbine on Immune Cell Function
Terminated·—·Phase 2/3·NCT00169104·23 enrolled
Show 4 more trials
GEfitinib Plus viNOrelbine in Advanced EGFR Mutated NSCLC. GENOA Trial
Unknown status·IIRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy·Phase 2·NCT02319577·80 enrolled
42 more indications
Chemotherapy7 trials
Show 4 more trials
Maintenance Oral Vinorelbine or Observation After Vinorelbine-Docetaxel First Line Chemotherapy in Advanced Breast Ca
Unknown status·CCancer Research Group - Collaborative Group, Beirut, Lebanon.·Phase 2·NCT02144194·65 enrolled
Small Cell Lung Cancer7 trials
Show 4 more trials
Study for Patients With Non Small Cell Lung Cancer (NSCLC)
Unknown status·—·Phase 2·NCT00168883·80 enrolled
Triple-Negative Breast Cancer4 trials
FDA018-ADC vs Investigator's Choice Chemotherapy to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer
Active, not recruiting·SShanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.·Phase 3·NCT06519370·350 enrolled
Show 1 more trial
Efficacy and Safety of PD-L1 Monoclonal Antibody Combined With Metronomic VEX in Advanced Triple-negative Breast Cancer
Not yet recruiting·—·Phase 2·NCT06229067·182 enrolled
Rhabdomyosarcoma3 trials
Evolutionary Therapy for Rhabdomyosarcoma
Active, not recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT04388839·12 enrolled
Lung Adenocarcinoma2 trials
Treatment2 trials
Hodgkin's Disease2 trials
Metastatic NSCLC2 trials
Neoadjuvant Chemotherapy2 trials
Cervical Cancer2 trials
Melanoma2 trials
Ovarian Cancer2 trials
Glioma2 trials
Elective1 trial
Study of Re-irradiation at Relapse Versus RT and Multiple Elective rt Courses
Unknown status·FFondazione IRCCS Istituto Nazionale dei Tumori, Milano·Phase 2·NCT03620032·54 enrolled
Patient Preference1 trial
Study of Patient Preference for Oral or Intravenous Vinorelbine in the Treatment of Advanced NSCLC
Completed·IIstituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS·Phase 4·NCT01848613·120 enrolled
Head and Neck Cancer1 trial
Gastric Adenocarcinoma1 trial
Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma
Completed·—·Phase 2·NCT00215462·32 enrolled
Induction Chemotherapy1 trial
Advanced Cancer1 trial
Elderly Patients1 trial
Biomarkers1 trial
Malignant Pleural Mesothelioma1 trial
Neoadjuvant1 trial
Malignant Mesothelioma1 trial
Prostate Cancer1 trial
Soft Tissue Sarcoma1 trial
Study of Gemcitabine and Vinorelbine in Soft Tissue Sarcomas
Completed·—·Phase 2·NCT00134641·40 enrolled
EGFR Mutation1 trial
Erlotinib in Post Radical Operation NSCLC Patients With EGFR Mutation
Unknown status·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT01683175·94 enrolled
Esophageal Cancer1 trial
Breast Carcinoma1 trial
Vinorelbine and Oxaliplatin (Vinox) With or Without Trastuzumab (Herceptin®) in Advanced Breast Carcinoma
Terminated·—·Phase 2·NCT00403988·40 enrolled
Relapsed/Refractory1 trial
Linperlisib Combined With Immunochemotherapy in Relapsed/Refractory LBCL
Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT06489808·89 enrolled
Induction Therapy1 trial
Leptomeningeal Metastasis1 trial
Metastatic Solid Tumors1 trial
Hematologic Malignancies1 trial
Unspecified1 trial
Regulatory
FDA Approval Timeline[5]
Dec 23, 1994
NAVELBINE
NDA NDA020388
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Navelbine drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Vinorelbine. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Tubulin Inhibitor[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company
- PPierre Fabre Medicament