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 38 indications[4].[1]
Navelbine is one of 764 small molecule programs targeting Glioma. It is currently in Approved.
38
Indications
225
Total Trials
33
Active Trials
763
Competitors
1
FDA Application
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 38 indications
Competition
Competitive Landscape
2828 competitors in Breast Cancer
#DrugCompanyPhaseTrials
1Navelbine
PPierre Fabre Medicament
Approved
Tecentriq
RochePreclinical
Megace
Bristol-Myers SquibbPreclinical
DATROWAY
Daiichi SankyoPreclinical
Lexiscan
AstellasPreclinical
Zinecard
CChildren's Oncology Group
Preclinical
Recentin
NNational Cancer Institute (NCI)
Preclinical
Chantix
PPrism Pharmaceuticals
Preclinical
Avastin
RochePreclinical
QS21
MMemorial Sloan Kettering Cancer Center
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Breast Cancer78 trials
Show 75 more trials
The AVIATOR Study: Trastuzumab and Vinorelbine With Avelumab OR Avelumab & Utomilumab in Advanced HER2+ Breast Cancer
Active, not recruiting·—·Phase 2·NCT03414658·100 enrolled
Trastuzumab and Vinorelbine in Advanced Breast Cancer
Terminated·—·Phase 2·NCT01185509·31 enrolled
Bevacizumab in Combination With Vinorelbine and Trastuzumab for HER2-Positive, Metastatic Breast Cancer
Completed·—·Phase 2·NCT00670982·29 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
Safety and Efficacy of Toripalimab in HER2- Metastatic Breast Cancer Patients Treated With Metronomic Vinorelbine
Unknown status·—·Phase 2·NCT04389073·138 enrolled
Trastuzumab in Combination With Vinorelbine or Taxane-Based Chemotherapy in Patients With Metastatic Breast Cancer
Completed·—·Phase 3·NCT00146549·250 enrolled
Non-Small Cell Lung Cancer23 trials
Show 20 more trials
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 Cancer9 trials
Show 6 more trials
Cetuximab and Vinorelbine in Elderly Subjects With Lung Cancer
Completed·—·Phase 2·NCT00165334·53 enrolled
Vinorelbine8 trials
Show 5 more trials
Effects of Granulocyte Colony-stimulating Factor (G-CSF), Trastuzumab, and Vinorelbine on Immune Cell Function
Terminated·—·Phase 2/3·NCT00169104·23 enrolled
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
Lymphoma7 trials
Show 4 more trials
Bendamustine, Gemcitabine and Vinorelbine (BeGEV) as Induction Therapy in Relapsed/Refractory Hodgkin's Lymphoma Patients
Unknown status·—·Phase 2·NCT01884441·59 enrolled
46 more indications
Chemotherapy6 trials
Show 3 more trials
Small Cell Lung Cancer6 trials
Study for Patients With Non Small Cell Lung Cancer (NSCLC)
Unknown status·—·Phase 2·NCT00168883·80 enrolled
Show 3 more trials
Rhabdomyosarcoma5 trials
Show 2 more trials
Evolutionary Therapy for Rhabdomyosarcoma
Active, not recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT04388839·12 enrolled
Triple-Negative Breast Cancer5 trials
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
Show 2 more 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
Cervical Cancer3 trials
Neoadjuvant Chemotherapy2 trials
Hodgkin's Disease2 trials
Ovarian Cancer2 trials
Metastatic NSCLC2 trials
Glioma2 trials
Melanoma2 trials
Treatment2 trials
Malignant Pleural Mesothelioma2 trials
Lung Adenocarcinoma2 trials
Metastatic Solid Tumors1 trial
Advanced Cancer1 trial
Hematologic Malignancies1 trial
Elderly Patients1 trial
Clinical Trial1 trial
Malignant Mesothelioma1 trial
Induction Chemotherapy1 trial
Leptomeningeal Metastasis1 trial
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
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
Adenocarcinoma1 trial
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
Soft Tissue Sarcoma1 trial
Study of Gemcitabine and Vinorelbine in Soft Tissue Sarcomas
Completed·—·Phase 2·NCT00134641·40 enrolled
Desmoplastic Small Round Cell Tumor1 trial
Breast Carcinoma1 trial
Vinorelbine and Oxaliplatin (Vinox) With or Without Trastuzumab (Herceptin®) in Advanced Breast Carcinoma
Terminated·—·Phase 2·NCT00403988·40 enrolled
Non-Small Cell Lung Carcinoma1 trial
Treatment in Patients With Advanced Non-Small Cell Lung Carcinoma and Interstitial Lung Disease
Not yet recruiting·IIntergroupe Francophone de Cancerologie Thoracique·Phase 2·NCT07420439·108 enrolled
Advanced or Metastatic Solid Tumors1 trial
Malignancies1 trial
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
Biomarkers1 trial
Neoadjuvant1 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