Last reviewed 2026-04-20 · How we verify

Navelbine (vinorelbine)

Navelbine works by binding to the Substance-K receptor, disrupting microtubule formation and inhibiting cell division.

Navelbine (vinorelbine) is a vinca alkaloid chemotherapy medication originally developed by Pierre Fabre. It targets the Substance-K receptor and is used to treat non-small cell lung cancer. Navelbine is a small molecule with a half-life of 26 hours and bioavailability of 27%. The medication is off-patent, with multiple generic manufacturers available. It was FDA-approved in 1994.

At a glance

Mechanism of action

Vinorelbine is vinca alkaloid that interferes with microtubule assembly. The antitumor activity of vinorelbine is thought to be due primarily to inhibition of mitosis at metaphase through its interaction with tubulin. Vinorelbine may also interfere with: 1) amino acid, cyclic AMP and glutathione metabolism, 2) calmodulin-dependent Ca++-transport ATPase activity, 3) cellular respiration, and 4) nucleic acid and lipid biosynthesis. Vinorelbine inhibited mitotic microtubule formation in intact mouse embryo tectal plates at concentration of uM inducing blockade of cells at metaphase, but produced depolymerization of axonal microtubules at concentration 40 uM, suggesting modest selectivity of vinorelbine for mitotic microtubules.

Approved indications

• Non-small cell lung cancer

Boxed warnings

• WARNING: MYELOSUPPRESSION Severe myelosuppression resulting in serious infection, septic shock, hospitalization and death can occur [see Warnings and Precautions ( 5.1 )]. Decrease the dose or withhold vinorelbine in accord with recommended dose modifications [see Dosage and Administration ( 2.2 )]. WARNING: MYELOSUPPRESSION See full prescribing information for complete boxed warning. Severe myelosuppression resulting in serious infection, septic shock, and death can occur ( 5.1 ). Decrease the dose or withhold vinorelbine in accord with recommended dose modifications ( 2.2 ).

Common side effects

• Leukopenia
• Neutropenia
• Anemia
• Increased aspartate aminotransferase
• Nausea
• Vomiting
• Constipation
• Asthenia
• Injection site reaction
• Peripheral neuropathy
• Increased total bilirubin
• Increased AST

Drug interactions

• fluconazole
• ketoconazole
• voriconazole

Key clinical trials

• Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma (PHASE3)
• A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20) (PHASE3)
• A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer (PHASE2)
• Precise Treatment for BLIS Subtype of TNBC in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer (PHASE3)
• CCCG-ALCL-2020 for Chinese Children and Adolescents With Newly Diagnosed High-risk ALCL (PHASE3)
• ctDNA-Guided Therapy for Relapsed/Refractory Hodgkin Lymphoma (PHASE2)
• The Efficacy and Safety of Trastuzumab Rezetecan (SHR-A1811) in HER2-Low Unresectable/Metastatic Breast Cancer Patients With Visceral Crisis (PHASE2)
• Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Breast Cancer w/Liver Dominant Disease (PHASE2)

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Navelbine CI brief — competitive landscape report
• Navelbine updates RSS · CI watch RSS
• Pierre Fabre portfolio CI