NAVELBINE
LOE ApproachingNDAINJECTIONINJECTABLEPriority Review
Approved
Dec 1994
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 8h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NAVELBINE (vinorelbine) is a semi-synthetic vinca alkaloid small-molecule chemotherapy administered by injection for non-small cell lung cancer, breast cancer, and peripheral T-cell lymphoma. It acts as a mitotic inhibitor disrupting microtubule dynamics to arrest cell division. The drug has been a cornerstone of oncology regimens since FDA approval in 1994.
LOE Approaching
As LOE approaches, commercial teams are likely focused on defending market share and managing transition planning rather than growth initiatives; smaller teams expected post-LOE.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
Addition of Aromatase at the Navelbine in Pretreated Metastatic Breast Cancer.
Started Oct 2015
120 enrolled
Breast Cancer
Combination of Weekly Chest Radiotherapy and Oral Navelbine for the Palliation of Advanced Non Small Cell Lung Cancer: A Phase I Study
Started Mar 2003
35 enrolled
Carcinoma, Non-Small-Cell Lung
Navelbine, Taxol, Herceptin and Neupogen in Stage IV Breast Cancer: A Phase I - II Trial
Started Mar 2001
38 enrolled
Breast Cancer
Phase II Study of Oxaliplatin and Navelbine for Second-Line Treatment of Advanced NSCLC.
40 enrolled
Previously Treated Metastatic Non-Small Cell Lung Cancer
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.