Overview
Docetaxel is a clinically well established anti-mitotic chemotherapy medication used for the treatment of different types of cancer, including breast, ovarian, and non-small cell lung cancer. Docetaxel is a complex diterpenoid molecule and a semisynthetic analogue of paclitaxel. Docetaxel reversibly binds to microtubulin with high affinity in a 1:1 stoichiometric ratio, allowing it to prevent cell division and promote to cell death. Compared to paclitaxel, docetaxel is two times more potent as an inhibitor of microtubule depolymerization. Docetaxel binds to microtubules but does not interact with dimeric tubulin. The use of docetaxel may lead to udesired outcomes such as hepatic impairment, hematologic effects, enterocolitis and neutropenic colitis, hypersensitivity reactions, fluid retention, second primary malignancies, embryo-fetal toxicity, and tumor lysis syndrome. Docetaxel was approved by the FDA in 1996 and is available in solution for injection for intravenous or parenteral administration.
Background
Docetaxel is a clinically well established anti-mitotic chemotherapy medication used for the treatment of different types of cancer, including breast, ovarian, and non-small cell lung cancer. Docetaxel is a complex diterpenoid molecule and a semisynthetic analogue of paclitaxel. Docetaxel reversibly binds to microtubulin with high affinity in a 1:1 stoichiometric ratio, allowing it to prevent cell division and promote to cell death. Compared to paclitaxel, docetaxel is two times more potent as an inhibitor of microtubule depolymerization. Docetaxel binds to microtubules but does not interact with dimeric tubulin. The use of docetaxel may lead to udesired outcomes such as hepatic impairment, hematologic effects, enterocolitis and neutropenic colitis, hypersensitivity reactions, fluid retention, second primary malignancies, embryo-fetal toxicity, and tumor lysis syndrome. Docetaxel was approved by the FDA in 1996 and is available in solution for injection for intravenous or parenteral administration.
Indication
Docetaxel is indicated as a single agent for the treatment of locally advanced or metastatic breast cancer after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC. It is also indicated as a single agent for locally advanced or metastatic non-small cell lung cancer (NSCLC) after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC. For the treatment of metastatic castration-resistant prostate cancer, docetaxel is indicated with prednisone. Docetaxel is also indicated with cisplatin and fluorouracil for untreated, advanced gastric adenocarcinoma, including the gastroesophageal junction, and with cisplatin and fluorouracil for induction treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN).
Associated Conditions
- Esophageal Cancer
- Ewing's Sarcoma
- Locally Advanced Breast Cancer (LABC)
- Metastatic Bladder Cancer
- Metastatic Breast Cancer
- Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC)
- Node Positive Breast Cancer
- Ovarian Cancer Metastatic
- Small Cell Lung Cancer (SCLC)
- Soft Tissue Sarcoma
- Advanced untreated gastric adenocarcinoma
- Locally advanced Squamous cell carcinoma of head and neck
- Locally advanced untreated non small cell lung cancer
- Metastatic untreated non small cell lung cancer
- Refractory, locally advanced Non small cell lung cancer
- Refractory, metastatic Non small cell lung cancer
- Refractory, metastatic hormone-refractory Prostate cancer
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/06/12 | Phase 2 | Not yet recruiting | |||
2025/06/12 | Phase 2 | Not yet recruiting | |||
2025/06/03 | Phase 2 | Not yet recruiting | |||
2025/05/25 | Phase 3 | Recruiting | |||
2025/05/01 | Phase 3 | Recruiting | |||
2025/04/27 | Phase 2 | Not yet recruiting | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | ||
2025/04/24 | Phase 1 | Recruiting | |||
2025/04/23 | Phase 2 | Recruiting | Glenn J. Hanna | ||
2025/04/17 | Phase 3 | Not yet recruiting | |||
2025/04/16 | Phase 3 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Winthrop U.S, a business of sanofi-aventis U.S. LLC | 0955-1022 | INTRAVENOUS | 160 mg in 8 mL | 12/7/2023 | |
Alembic Pharmaceuticals Inc. | 62332-678 | INTRAVENOUS | 10 mg in 1 mL | 9/4/2023 | |
Meitheal Pharmaceuticals Inc | 71288-144 | INTRAVENOUS | 10 mg in 1 mL | 2/22/2022 | |
AuroMedics Pharma LLC | 55150-380 | INTRAVENOUS | 10 mg in 1 mL | 2/16/2021 | |
Amneal Pharmaceuticals LLC | 70121-1223 | INTRAVENOUS | 160 mg in 8 mL | 3/21/2023 | |
Gland Pharma Limited | 68083-401 | INTRAVENOUS | 10 mg in 1 mL | 6/16/2023 | |
Xiromed LLC | 70700-176 | INTRAVENOUS | 10 mg in 1 mL | 10/25/2021 | |
Baxter Healthcare Corporation | 43066-010 | INTRAVENOUS | 10 mg in 1 mL | 12/20/2017 | |
Mylan Institutional LLC | 67457-533 | INTRAVENOUS | 10 mg in 1 mL | 9/5/2023 | |
Sun Pharmaceutical Industries, Inc. | 47335-323 | INTRAVENOUS | 20 mg in 1 mL | 2/4/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 11/27/1995 | ||
Authorised | 5/22/2012 | ||
Authorised | 5/22/2012 | ||
Authorised | 5/22/2012 | ||
Authorised | 5/22/2012 | ||
Authorised | 11/27/1995 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
DOCEHOPE Concentrate for Solution for Infusion 80 mg/ 4 ml | SIN16942P | INFUSION, SOLUTION CONCENTRATE | 80 mg / 4 ml | 2/7/2024 | |
Hospira Docetaxel Concentrate for Solution for Infusion 20 mg / 2 ml | SIN14218P | INFUSION, SOLUTION | 20mg per 2ml | 8/27/2012 | |
Taxotere Concentrate for Solution for Infusion 20mg/ml | SIN14106P | INFUSION, SOLUTION CONCENTRATE | 20mg/ml | 2/16/2012 | |
Taxotere Concentrate for Solution for Infusion 80mg/4ml | SIN14107P | INFUSION, SOLUTION CONCENTRATE | 80mg/4ml | 2/16/2012 | |
TEXTAS 80 CONCENTRATE FOR SOLUTION FOR INFUSION 80 MG/ 4 ML VIAL | SIN15589P | INJECTION, SOLUTION, CONCENTRATE | 80 mg / 4 mL | 12/3/2018 | |
Daxotel Concentrate for Solution for Infusion 20mg/ml | SIN15109P | INJECTION, SOLUTION, CONCENTRATE | 20.0mg/ml | 10/26/2016 | |
DOCETAXEL STADA CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/ML | SIN15393P | INJECTION, SOLUTION, CONCENTRATE | 20mg/ml | 12/12/2017 | |
DOCETAXEL ADVAGEN CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/ML | SIN15449P | INFUSION, SOLUTION CONCENTRATE | 20mg/ml | 3/13/2018 | |
Hospira Docetaxel Concentrate for Solution for Infusion 80 mg / 8 ml | SIN14219P | INFUSION, SOLUTION | 80mg per 8ml | 8/27/2012 | |
DOCEHOPE Concentrate for Solution for Infusion 20 mg/ ml | SIN16943P | INFUSION, SOLUTION CONCENTRATE | 20 mg / ml | 2/7/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Docetaxel Injection | 国药准字HJ20140086 | 化学药品 | 注射剂 | 3/29/2023 | |
Docetaxel Injection | 国药准字HJ20140085 | 化学药品 | 注射剂 | 3/29/2023 | |
Docetaxel Injection | 国药准字H20093744 | 化学药品 | 注射剂 | 2/25/2020 | |
Docetaxel Injection | 国药准字H20198001 | 化学药品 | 注射剂 | 10/16/2023 | |
Docetaxel Injection | 国药准字H20051045 | 化学药品 | 注射剂 | 7/15/2024 | |
Docetaxel Injection | 国药准字H20237179 | 化学药品 | 注射剂 | 12/20/2023 | |
Docetaxel Injection | 国药准字H20103665 | 化学药品 | 注射剂(注射液) | 11/4/2020 | |
Docetaxel Injection | 国药准字H20198003 | 化学药品 | 注射剂 | 10/16/2023 | |
Docetaxel Injection | 国药准字H20093755 | 化学药品 | 注射剂 | 5/14/2024 | |
Docetaxel Injection | 国药准字H20080366 | 化学药品 | 注射剂 | 8/31/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
DAXOTEL CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/1ML | N/A | N/A | N/A | 1/21/2025 | |
DOCETAXEL STADA CONCENTRATE FOR SOLUTION FOR INFUSION 80MG/4ML | N/A | N/A | N/A | 4/11/2014 | |
DAXOTEL CONCENTRATE FOR SOLUTION FOR INFUSION 80MG/4ML | N/A | N/A | N/A | 1/21/2025 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
DOCETAXEL SANDOZ | 170109 | Medicine | A | 4/20/2011 | |
DOCETAXEL WKT docetaxel 160mg/8mL concentrate for solution for infusion glass vial | 272860 | Medicine | A | 12/4/2017 | |
Docetaxel Pfizer 10mg/mL (130mg/13mL) Concentrate for Solution for Infusion | 206275 | Medicine | A | 2/20/2013 | |
DOCETAXEL WKT docetaxel 80mg/4mL concentrate for solution for infusion glass vial | 272863 | Medicine | A | 12/4/2017 | |
DOCETAXEL WOCKHARDT docetaxel 20mg/1mL concentrated solution for injection vial | 272864 | Medicine | A | 12/4/2017 | |
Hospira Docetaxel for Injection 160 mg/16 mL multi dose vial | 181165 | Medicine | A | 3/17/2011 | |
DBL DOCETAXEL CONCENTRATED INJECTION 80mg/8mL concentrated injection vial | 163801 | Medicine | A | 12/6/2010 | |
Hospira Docetaxel Injection, 120 mg/12 mL, single vial | 216602 | Medicine | A | 10/25/2013 | |
TAXOCCORD 20 mg/1 mL docetaxel concentrated injection 20 mg/1 mL glass vial | 209467 | Medicine | A | 2/17/2015 | |
Docetaxel Injection, USP 20 mg/mL | 277764 | Medicine | A | 7/12/2016 |