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Navelbine (Vinorelbine Tartrate) - Summary



  • Severe myelosuppression resulting in serious infection, septic shock, hospitalization and death may occur [see Warnings¬†and Precautions].
  • Decrease the dose or withhold NAVELBINE in accord with recommended dose modifications [see¬† Dosage and Administration].



NAVELBINE (vinorelbine tartrate) is a semi-synthetic vinca alkaloid for intravenous injection.

NAVELBINE is indicated:

  • In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
  • As a single agent, for the treatment of patients with metastatic NSCLC

See all Navelbine indications & dosage >>


Media Articles Related to Navelbine (Vinorelbine)

Keytruda OK'd for Non-Small Cell Lung Cancer
Source: MedPageToday.com - medical news plus CME for physicians [2015.10.02]
(MedPage Today) -- For NSCLC not responding to other drugs and expressing PD-L1

Study finds drug improves survival for patients with non-small cell lung cancer
Source: Clinical Trials / Drug Trials News From Medical News Today [2015.09.28]
A new phase 3 trial finds that overall survival is longer for patient with non-small cell lung cancer treated with the drug nivolumab compared with chemotherapy drug docetaxel.

Further evidence presented for the potential of AZD9291 in first-line and pre-treated non-small cell lung cancer
Source: Lung Cancer News From Medical News Today [2015.09.09]
AstraZeneca has announced updated data on AZD9291 in first-line patients with epidermal growth factor receptor mutation (EGFRm) positive advanced non-small cell lung cancer (NSCLC) and...

Atezolizumab: Another Immunotherapy Active in Lung Cancer
Source: Medscape Hematology-Oncology Headlines [2015.09.27]
Another immunotherapy is showing promise in non-small cell lung cancer. Atezolizumab is in a race with several others to join the already-approved nivolumab.
Medscape Medical News

Study defines clinical trials likely to exclude patients with brain metastases
Source: Lung Cancer News From Medical News Today [2015.09.10]
Non-small cell lung cancer frequently spreads to the central nervous system (CNS), but patients with CNS metastases may be excluded from clinical trials of new drugs.

more news >>

Published Studies Related to Navelbine (Vinorelbine)

Docetaxel vs. vinorelbine in elderly patients with advanced non--small-cell lung cancer: a hellenic oncology research group randomized phase III study. [2011.05]
BACKGROUND/PURPOSE: This study compared front-line treatment with docetaxel or vinorelbine in elderly patients with advanced/metastatic non-small-cell lung cancer (NSCLC)... CONCLUSIONS: Docetaxel has an efficacy comparable to that of vinorelbine as first-line treatment in elderly patients with NSCLC and has an acceptable toxicity profile. The trial was closed prematurely because of low accrual, thus limiting the strength of the conclusions derived. Copyright (c) 2011. Published by Elsevier Inc.

A multicenter prospective phase II randomized trial of epirubicin/vinorelbine versus pegylated liposomal doxorubicin/vinorelbine as first-line treatment in advanced breast cancer. A GOIM study. [2011.04.12]
BACKGROUND: To evaluate activity and tolerability of two anthracycline-containing regimens as first-line treatment for anthracycline-naive relapsed breast cancer patients... CONCLUSIONS: Both anthracycline- containing regimens evaluated in the present study seem to be active and with a satisfactory tolerability in anthracycline-naive relapsed breast cancer patients.

Paclitaxel and gemcitabine versus paclitaxel and vinorelbine in patients with advanced non-small-cell lung cancer. A phase III study of the Hellenic Cooperative Oncology Group (HeCOG). [2011.04]
BACKGROUND: Paclitaxel (Taxol) and vinorelbine have shown synergism of cytotoxic effects in vitro and clinical activity in phase I and II studies. This combination was compared prospectively with the paclitaxel/gemcitabine regimen in non-operable non-small-cell lung cancer... CONCLUSION: Although response rate, PFS and survival were non-different in both groups, toxicity was significantly worse in group B and therefore further investigation of P-Vin is of no value. (c) The Author 2010. Published by Oxford University Press on behalf of the European Society for Medical Oncology.

Randomised phase II trial of gemcitabine plus vinorelbine vs gemcitabine plus cisplatin vs gemcitabine plus capecitabine in patients with pretreated metastatic breast cancer. [2011.03.29]
BACKGROUND: An increasing proportion of patients are exposed to anthracyclines and/or taxanes in the adjuvant or neoadjuvant setting. Re-exposure in the metastatic stage is limited by drug resistance, thus evaluation of non-cross-resistant regimens is mandatory... CONCLUSIONS: This randomised phase II trial has revealed comparable results for three gemcitabine-based regimens regarding treatment efficacy and toxicity. Gemcitabine-based chemotherapy appears to be a worthwhile treatment option for pretreated patients with metastatic breast cancer.

Second-line paclitaxel/carboplatin versus vinorelbine/carboplatin in patients who have advanced non-small-cell lung cancer pretreated with non-platinum-based chemotherapy: a multicenter randomized phase II study. [2011.03]
PURPOSE: This study evaluates the activity and toxicity of the paclitaxel/carboplatin (PC) doublet versus vinorelbine/carboplatin (VC) doublet as second-line treatment in patients who have advanced non-small-cell lung cancer (NSCLC)... CONCLUSIONS: Platinum-based doublets with either paclitaxel or vinorelbine in patients with advanced/metastatic NSCLC pretreated with front-line docetaxel/gemcitabine show comparable efficacy when used in the second-line setting. Copyright (c) 2011. Published by Elsevier Inc.

more studies >>

Clinical Trials Related to Navelbine (Vinorelbine)

Study of Oral Vinorelbine and Erlotinib in Non-Small Cell Lung Cancer [Completed]
The purpose of this study is to define the schedule and dose of oral vinorelbine (Navelbine) to be used with erlotinib in non-small cell lung cancer.

Maintenance Oral Vinorelbine or Observation After Vinorelbine-Docetaxel First Line Chemotherapy in Advanced Breast Ca [Recruiting]
This 2 arms study will assess the efficacy and safety of the Vinorelbine-Docetaxel combination given as an initial upfront treatment (first line) to all metastatic breast cancer patients enrolled. Patients having a disease control following initial treatment, will be randomized to either oral Vinorelbine maintenance arm or Observation arm. The trial will also compare the efficacy and safety of maintenance oral Vinorelbine versus Observation.

Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in HER-2 Positive Breast Cancer [Completed]
The purpose of this study is to find out what effects the preoperative combination therapies of herceptin/navelbine or herceptin/taxotere/carboplatin will have on patients with early stage HER-2 positive breast cancer.

Phase II Trial With Metronomic, Capecitabine Plus Oral Vinorelbine for Metastatic Breast Cancer [Recruiting]

Preoperative Herceptin and Navelbine for Breast Cancer [Active, not recruiting]
The purpose of this study is to find out what effects the preoperative combination therapy of herceptin and navelbine have on HER-2 positive breast cancer.

more trials >>

Reports of Suspected Navelbine (Vinorelbine) Side Effects

Febrile Neutropenia (10)Confusional State (8)Tachycardia (8)Tongue Neoplasm Malignant Stage Unspecified (8)Diarrhoea (7)Neoplasm Progression (6)Pyrexia (6)Pleural Effusion (6)Cardiotoxicity (6)Neutropenia (6)more >>

Page last updated: 2015-10-02

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