Overview
Gemcitabine is a nucleoside analog and a chemotherapeutic agent. It was originally investigated for its antiviral effects, but it is now used as an anticancer therapy for various cancers. Gemcitabine is a cytidine analog with two fluorine atoms replacing the hydroxyl on the ribose. As a prodrug, gemcitabine is transformed into its active metabolites that work by replacing the building blocks of nucleic acids during DNA elongation, arresting tumour growth and promoting apoptosis of malignant cells. The structure, metabolism, and mechanism of action of gemcitabine are similar to cytarabine, but gemcitabine has a wider spectrum of antitumour activity. Gemcitabine is marketed as Gemzar and it is available as intravenous injection. It is approved by the FDA to treat advanced ovarian cancer in combination with carboplatin, metastatic breast cancer in combination with paclitaxel, non-small cell lung cancer in combination with cisplatin, and pancreatic cancer as monotherapy. It is also being investigated in other cancer and tumour types.
Background
Gemcitabine is a nucleoside analog and a chemotherapeutic agent. It was originally investigated for its antiviral effects, but it is now used as an anticancer therapy for various cancers. Gemcitabine is a cytidine analog with two fluorine atoms replacing the hydroxyl on the ribose. As a prodrug, gemcitabine is transformed into its active metabolites that work by replacing the building blocks of nucleic acids during DNA elongation, arresting tumour growth and promoting apoptosis of malignant cells. The structure, metabolism, and mechanism of action of gemcitabine are similar to cytarabine, but gemcitabine has a wider spectrum of antitumour activity. Gemcitabine is marketed as Gemzar and it is available as intravenous injection. It is approved by the FDA to treat advanced ovarian cancer in combination with carboplatin, metastatic breast cancer in combination with paclitaxel, non-small cell lung cancer in combination with cisplatin, and pancreatic cancer as monotherapy. It is also being investigated in other cancer and tumour types.
Indication
Gemcitabine is a chemotherapeutic agent used as monotherapy or in combination with other anticancer agents. In combination with carboplatin, it is indicated for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. Gemcitabine in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. In combination with cisplatin, gemcitabine is indicated for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer (NSCLC). Dual therapy with cisplatin is also used to treat patients with Stage IV (locally advanced or metastatic) transitional cell carcinoma (TCC) of the bladder. Gemcitabine is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. Gemcitabine is indicated for patients previously treated with fluorouracil.
Associated Conditions
- Advanced Ovarian Cancer
- Bladder Transitional Cell Carcinoma Stage IV
- Carcinoma of the Head and Neck
- Cervical Cancer
- Cutaneous T-Cell Lymphoma (CTCL)
- Hodgkins Disease (HD)
- Mesothelioma
- Metastatic Breast Cancer
- Pancreatic Adenocarcinoma Locally Advanced
- Small Cell Lung Cancer (SCLC)
- Stage IIIA Non Small Cell Lung Cancer
- Stage IIIB Non-Small Cell Lung Cancer
- Stage IV Non-small Cell Lung Cancer (NSCLC)
- Stage 4 Pancreatic adenocarcinoma
Clinical Trials
View More Clinical Trials
Sign in to access the complete clinical trial database with detailed study information.
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2009/07/31 | Phase 1 | Completed | |||
2009/07/20 | Phase 2 | Completed | Institut du Cancer de Montpellier - Val d'Aurelle | ||
2009/07/20 | Phase 3 | Completed | |||
2009/07/16 | Phase 2 | Terminated | |||
2009/07/15 | Phase 2 | Completed | |||
2009/07/13 | Phase 1 | Terminated | |||
2009/07/10 | Phase 2 | Completed | |||
2009/06/26 | Phase 2 | Completed | Henry M. Jackson Foundation for the Advancement of Military Medicine | ||
2009/06/18 | Phase 2 | Terminated | |||
2009/06/15 | Phase 3 | Terminated | French Innovative Leukemia Organisation |
FDA Drug Approvals
View More FDA Approvals
Sign in to access additional FDA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
No FDA approvals found for this drug. |
EMA Drug Approvals
View More EMA Approvals
Sign in to access additional EMA-approved drug information with detailed regulatory data.
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
View More HSA Approvals
Sign in to access additional HSA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
View More NMPA Approvals
Sign in to access additional NMPA-approved drug information with detailed regulatory data.
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
View More PPB Approvals
Sign in to access additional PPB-approved drug information with detailed regulatory data.
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
View More TGA Approvals
Sign in to access additional TGA-approved drug information with detailed regulatory data.
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
No TGA approvals found for this drug. |