Difference between revisions of "Docetaxel (Taxotere)"
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==General information== | ==General information== | ||
| − | Class/mechanism: Taxane; disrupts normal microtubular function. | + | Class/mechanism: Taxane; disrupts normal microtubular function. Binds to free tubulin, promotes their assembly into stable microtubules, and inhibits their disassembly, which inhibits mitosis.<ref name="insert">[http://products.sanofi.us/taxotere/taxotere.pdf Docetaxel (Taxotere) package insert]</ref><ref>[[:File:Docetaxel.pdf | Docetaxel (Taxotere) package insert (locally hosted backup)]]</ref> |
<br>Route: IV | <br>Route: IV | ||
<br>Extravasation: [[irritant]], rare [[vesicant]] | <br>Extravasation: [[irritant]], rare [[vesicant]] | ||
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref> | For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref> | ||
| + | |||
| + | ==Diseases for which it is established ''(work in progress)''== | ||
| + | *[[Breast cancer]] | ||
| + | *[[Gastric cancer]] | ||
| + | *[[Head and neck cancer]] | ||
| + | *[[Non-small cell lung cancer]] | ||
| + | **[[Non-small cell lung cancer, nonsquamous]] | ||
| + | **[[Non-small cell lung cancer, squamous]] | ||
| + | *[[Ovarian cancer]] | ||
| + | *[[Prostate cancer]] | ||
==Diseases for which it is used== | ==Diseases for which it is used== | ||
*[[Carcinoma of unknown primary]] | *[[Carcinoma of unknown primary]] | ||
*[[Anal cancer]] | *[[Anal cancer]] | ||
| − | |||
| − | |||
*[[Cervical cancer]] | *[[Cervical cancer]] | ||
*[[Esophageal cancer]] | *[[Esophageal cancer]] | ||
| Line 16: | Line 24: | ||
**[[Esophageal squamous cell carcinoma]] | **[[Esophageal squamous cell carcinoma]] | ||
*[[Ewing sarcoma]] | *[[Ewing sarcoma]] | ||
| − | |||
| − | |||
*[[Leiomyosarcoma]] | *[[Leiomyosarcoma]] | ||
*[[Melanoma]] | *[[Melanoma]] | ||
*[[Nasopharyngeal carcinoma]] | *[[Nasopharyngeal carcinoma]] | ||
| − | |||
*[[Osteosarcoma]] | *[[Osteosarcoma]] | ||
| − | |||
*[[Pancreatic cancer]] | *[[Pancreatic cancer]] | ||
*[[Penile cancer]] | *[[Penile cancer]] | ||
| − | |||
*[[Soft tissue sarcoma]] | *[[Soft tissue sarcoma]] | ||
*[[Small cell lung cancer]] | *[[Small cell lung cancer]] | ||
| + | *[[Urothelial carcinoma]] | ||
==Patient drug information== | ==Patient drug information== | ||
*[http://products.sanofi.us/taxotere/taxotere.pdf Docetaxel (Taxotere) package insert]<ref name="insert"></ref> | *[http://products.sanofi.us/taxotere/taxotere.pdf Docetaxel (Taxotere) package insert]<ref name="insert"></ref> | ||
| − | *[https://chemocare.com/ | + | *[https://chemocare.com/druginfo/docetaxel.aspx Docetaxel (Taxotere) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/docetaxel.aspx Docetaxel (Taxotere) patient drug information (Chemocare)]</ref> |
*[http://www.uptodate.com/contents/docetaxel-patient-drug-information Docetaxel (Taxotere) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/docetaxel-patient-drug-information Docetaxel (Taxotere) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/docetaxel-patient-drug-information Docetaxel (Taxotere) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/docetaxel-patient-drug-information Docetaxel (Taxotere) patient drug information (UpToDate)]</ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
===[[Breast cancer]]=== | ===[[Breast cancer]]=== | ||
| − | *''' | + | *'''1996-05-14: Initial accelerated approval''' for treatment of patients with metastatic [[Breast cancer | breast cancer]] who have progressed during [[:Category:Anthracyclines|anthracycline-based]] therapy. ''(Based on TAX 303 & TAX 304)'' |
| − | * | + | *'''1996-05-14: Initial accelerated approval''' for treatment of patients with locally advanced [[Breast cancer | breast cancer]] who have relapsed during [[:Category:Anthracyclines|anthracycline-based]] adjuvant therapy. ''(Based on TAX 303 & TAX 304)'' |
| − | * | + | *1998-06-22: Converted to regular approval and indication revised for the treatment of patients with locally advanced or metastatic [[Breast cancer | breast cancer]] after failure of prior chemotherapy. ''(No longer limited to prior anthracycline-based chemotherapy exposure; based on TAX 313)'' |
| + | *2004-08-18: Breast cancer indication expanded: in combination with [[Doxorubicin (Adriamycin) | doxorubicin]] and [[Cyclophosphamide (Cytoxan) | cyclophosphamide]] is indicated for the adjuvant treatment of patients with operable node-positive [[Breast cancer | breast cancer]]. ''(No longer limited to the relapsed or metastatic setting; based on BCIRG 001)'' | ||
| + | |||
===[[Gastric cancer]]=== | ===[[Gastric cancer]]=== | ||
| − | * | + | *2006-03-22: Label expanded as follows: in combination with [[Cisplatin (Platinol) | cisplatin]] and [[Fluorouracil (5-FU) | fluorouracil]] is indicated for the treatment of patients with advanced [[Gastric cancer | gastric adenocarcinoma]], including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for advanced disease. ''(New disease entity; based on TAX 325)'' |
===[[Head and neck cancer]]=== | ===[[Head and neck cancer]]=== | ||
| − | *10 | + | *2006-10-17: Label expanded as follows: in combination with [[Cisplatin (Platinol) | cisplatin]] and [[Fluorouracil (5-FU) | fluorouracil]] is indicated for the induction treatment of patients with inoperable locally advanced [[Head and neck cancer | squamous cell carcinoma of the head and neck (SCCHN)]]. ''(New disease entity; based on TAX 323)'' |
| − | * | + | *2007-09-28: Approved for use in combination with [[Cisplatin (Platinol) | cisplatin]] and [[fluorouracil (5-FU)]] for the induction treatment of patients with locally advanced [[Head and neck cancer |squamous cell carcinoma of the head and neck (SCCHN)]]. ''(Requirement that disease be inoperable was removed; based on TAX 324)'' |
===[[Non-small cell lung cancer]]=== | ===[[Non-small cell lung cancer]]=== | ||
| − | *12 | + | *1999-12-23: Label expanded to include treatment of patients with locally advanced or metastatic [[Non-small cell lung cancer | non-small cell lung cancer]] after failure of prior [[Regimen_classes#Platinum-based_regimen | platinum-based chemotherapy]]. ''(New disease entity; based on TAX 317 & TAX 320)'' |
| − | *11 | + | *2002-11-27: Label expanded: In combination with [[Cisplatin (Platinol) | cisplatin]] is indicated for the treatment of patients with unresectable, locally advanced or metastatic [[Non-small cell lung cancer | non-small cell lung cancer]] who have not previously received chemotherapy for this condition. ''(No longer limited to prior chemotherapy exposure; based on TAX 326)'' |
===[[Prostate cancer]]=== | ===[[Prostate cancer]]=== | ||
| − | * | + | *2004-05-19: Label expanded as follows: in combination with [[Prednisone (Sterapred) | prednisone]] is indicated for the treatment of patients with androgen independent (hormone refractory) metastatic [[Prostate cancer | prostate cancer]]. ''(New disease entity; based on TAX 327)'' |
==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
| − | *11 | + | *1995-11-27: Initial marketing authorization as Taxotere |
===[[Breast cancer]]=== | ===[[Breast cancer]]=== | ||
*Taxotere in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer. | *Taxotere in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer. | ||
| − | *Taxotere in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-negative breast cancer. | + | *2010-07-01: Taxotere in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-negative [[breast cancer]]. Adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. ''(Based on GEICAM 9805)'' |
| − | |||
*Taxotere in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. | *Taxotere in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. | ||
*Taxotere monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. | *Taxotere monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. | ||
| Line 63: | Line 68: | ||
*Taxotere in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. | *Taxotere in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. | ||
===[[Gastric cancer|Gastric adenocarcinoma]]=== | ===[[Gastric cancer|Gastric adenocarcinoma]]=== | ||
| − | *Taxotere in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. | + | *2006-04-27: Taxotere in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic [[Gastric cancer|gastric adenocarcinoma]], including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. |
===[[Head and neck cancer]]=== | ===[[Head and neck cancer]]=== | ||
| − | *Taxotere in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck. | + | *2006-10-23: Extension of indication for induction treatment in combination with cisplatin and 5-fluorouracil of patients with inoperable locally advanced [[Head and neck cancer|squamous cell carcinoma of the head and neck]]. |
| + | *2007-11-23: Taxotere in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced [[Head and neck cancer|squamous cell carcinoma of the head and neck]]. | ||
===[[Non-small cell lung cancer]]=== | ===[[Non-small cell lung cancer]]=== | ||
*Taxotere is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. | *Taxotere is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. | ||
*Taxotere in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. | *Taxotere in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. | ||
===[[Prostate cancer]]=== | ===[[Prostate cancer]]=== | ||
| − | *Taxotere in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. | + | *Uncertain date: Taxotere in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic [[prostate cancer]]. |
| + | |||
| + | ==History of changes in Health Canada indication== | ||
| + | *1995-07-21: Initial notice of compliance | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2005-08-18: New indication for the treatment of [[endometrial cancer|cancer of the uterus body]]. | ||
| + | *2008-08-29: New indication and a new dosage for the treatment of [[prostate cancer]]. | ||
==Also known as== | ==Also known as== | ||
| − | *'''Code names:''' NSC 628503, RP 56976 | + | *'''Code names:''' NSC-628503, RP-56976 |
*'''Brand names:''' Asodocel, Daxotel, Docefrez, Docegem, Doceglob, Docemax, Docenat, Docepar, Docetax, Docetec, Docetere, DoceXan, Docshil, Dolectran, Doxel, Doxetal, Hentaxel, Neocel, Oncodocel, Plustaxano, Sibatere, Taceedo, Taxe-RTU, Taxespira, Taxewell, Taxotere, Texot, Trixotene, Uvtere | *'''Brand names:''' Asodocel, Daxotel, Docefrez, Docegem, Doceglob, Docemax, Docenat, Docepar, Docetax, Docetec, Docetere, DoceXan, Docshil, Dolectran, Doxel, Doxetal, Hentaxel, Neocel, Oncodocel, Plustaxano, Sibatere, Taceedo, Taxe-RTU, Taxespira, Taxewell, Taxotere, Texot, Trixotene, Uvtere | ||
| Line 88: | Line 100: | ||
[[Category:Anal cancer medications]] | [[Category:Anal cancer medications]] | ||
| + | [[Category:Breast cancer medications]] | ||
[[Category:Carcinoma of unknown primary medications]] | [[Category:Carcinoma of unknown primary medications]] | ||
| − | |||
| − | |||
[[Category:Cervical cancer medications]] | [[Category:Cervical cancer medications]] | ||
[[Category:Esophageal adenocarcinoma medications]] | [[Category:Esophageal adenocarcinoma medications]] | ||
| Line 102: | Line 113: | ||
[[Category:Nasopharyngeal carcinoma medications]] | [[Category:Nasopharyngeal carcinoma medications]] | ||
[[Category:Non-small cell lung cancer medications]] | [[Category:Non-small cell lung cancer medications]] | ||
| + | [[Category:Non-small cell lung cancer, nonsquamous medications]] | ||
| + | [[Category:Non-small cell lung cancer, squamous medications]] | ||
[[Category:Osteosarcoma medications]] | [[Category:Osteosarcoma medications]] | ||
[[Category:Ovarian cancer medications]] | [[Category:Ovarian cancer medications]] | ||
| Line 109: | Line 122: | ||
[[Category:Soft tissue sarcoma medications]] | [[Category:Soft tissue sarcoma medications]] | ||
[[Category:Small cell lung cancer medications]] | [[Category:Small cell lung cancer medications]] | ||
| + | [[Category:Urothelial carcinoma medications]] | ||
[[Category:EMA approved in 1995]] | [[Category:EMA approved in 1995]] | ||
[[Category:FDA approved in 1996]] | [[Category:FDA approved in 1996]] | ||
| + | [[Category:Health Canada approved in 1995]] | ||
[[Category:WHO Essential Cancer Medicine]] | [[Category:WHO Essential Cancer Medicine]] | ||
Revision as of 23:52, 16 September 2023
General information
Class/mechanism: Taxane; disrupts normal microtubular function. Binds to free tubulin, promotes their assembly into stable microtubules, and inhibits their disassembly, which inhibits mitosis.[1][2]
Route: IV
Extravasation: irritant, rare vesicant
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is established (work in progress)
- Breast cancer
- Gastric cancer
- Head and neck cancer
- Non-small cell lung cancer
- Ovarian cancer
- Prostate cancer
Diseases for which it is used
- Carcinoma of unknown primary
- Anal cancer
- Cervical cancer
- Esophageal cancer
- Ewing sarcoma
- Leiomyosarcoma
- Melanoma
- Nasopharyngeal carcinoma
- Osteosarcoma
- Pancreatic cancer
- Penile cancer
- Soft tissue sarcoma
- Small cell lung cancer
- Urothelial carcinoma
Patient drug information
- Docetaxel (Taxotere) package insert[1]
- Docetaxel (Taxotere) patient drug information (Chemocare)[3]
- Docetaxel (Taxotere) patient drug information (UpToDate)[4]
History of changes in FDA indication
Breast cancer
- 1996-05-14: Initial accelerated approval for treatment of patients with metastatic breast cancer who have progressed during anthracycline-based therapy. (Based on TAX 303 & TAX 304)
- 1996-05-14: Initial accelerated approval for treatment of patients with locally advanced breast cancer who have relapsed during anthracycline-based adjuvant therapy. (Based on TAX 303 & TAX 304)
- 1998-06-22: Converted to regular approval and indication revised for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. (No longer limited to prior anthracycline-based chemotherapy exposure; based on TAX 313)
- 2004-08-18: Breast cancer indication expanded: in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer. (No longer limited to the relapsed or metastatic setting; based on BCIRG 001)
Gastric cancer
- 2006-03-22: Label expanded as follows: in combination with cisplatin and fluorouracil is indicated for the treatment of patients with advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for advanced disease. (New disease entity; based on TAX 325)
Head and neck cancer
- 2006-10-17: Label expanded as follows: in combination with cisplatin and fluorouracil is indicated for the induction treatment of patients with inoperable locally advanced squamous cell carcinoma of the head and neck (SCCHN). (New disease entity; based on TAX 323)
- 2007-09-28: Approved for use in combination with cisplatin and fluorouracil (5-FU) for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN). (Requirement that disease be inoperable was removed; based on TAX 324)
Non-small cell lung cancer
- 1999-12-23: Label expanded to include treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy. (New disease entity; based on TAX 317 & TAX 320)
- 2002-11-27: Label expanded: In combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer who have not previously received chemotherapy for this condition. (No longer limited to prior chemotherapy exposure; based on TAX 326)
Prostate cancer
- 2004-05-19: Label expanded as follows: in combination with prednisone is indicated for the treatment of patients with androgen independent (hormone refractory) metastatic prostate cancer. (New disease entity; based on TAX 327)
History of changes in EMA indication
- 1995-11-27: Initial marketing authorization as Taxotere
Breast cancer
- Taxotere in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer.
- 2010-07-01: Taxotere in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-negative breast cancer. Adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. (Based on GEICAM 9805)
- Taxotere in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.
- Taxotere monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.
- Taxotere in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.
- Taxotere in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.
Gastric adenocarcinoma
- 2006-04-27: Taxotere in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.
Head and neck cancer
- 2006-10-23: Extension of indication for induction treatment in combination with cisplatin and 5-fluorouracil of patients with inoperable locally advanced squamous cell carcinoma of the head and neck.
- 2007-11-23: Taxotere in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
Non-small cell lung cancer
- Taxotere is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.
- Taxotere in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition.
Prostate cancer
- Uncertain date: Taxotere in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
History of changes in Health Canada indication
- 1995-07-21: Initial notice of compliance
History of changes in PMDA indication
- 2005-08-18: New indication for the treatment of cancer of the uterus body.
- 2008-08-29: New indication and a new dosage for the treatment of prostate cancer.
Also known as
- Code names: NSC-628503, RP-56976
- Brand names: Asodocel, Daxotel, Docefrez, Docegem, Doceglob, Docemax, Docenat, Docepar, Docetax, Docetec, Docetere, DoceXan, Docshil, Dolectran, Doxel, Doxetal, Hentaxel, Neocel, Oncodocel, Plustaxano, Sibatere, Taceedo, Taxe-RTU, Taxespira, Taxewell, Taxotere, Texot, Trixotene, Uvtere
References
Categories:
- Drugs
- Intravenous medications
- Irritant
- Vesicant
- Microtubule inhibitors
- Taxanes
- Anal cancer medications
- Breast cancer medications
- Carcinoma of unknown primary medications
- Cervical cancer medications
- Esophageal adenocarcinoma medications
- Esophageal cancer medications
- Esophageal squamous cell carcinoma medications
- Ewing sarcoma medications
- Gastric cancer medications
- Head and neck cancer medications
- Leiomyosarcoma medications
- Melanoma medications
- Nasopharyngeal carcinoma medications
- Non-small cell lung cancer medications
- Non-small cell lung cancer, nonsquamous medications
- Non-small cell lung cancer, squamous medications
- Osteosarcoma medications
- Ovarian cancer medications
- Pancreatic cancer medications
- Penile cancer medications
- Prostate cancer medications
- Soft tissue sarcoma medications
- Small cell lung cancer medications
- Urothelial carcinoma medications
- EMA approved in 1995
- FDA approved in 1996
- Health Canada approved in 1995
- WHO Essential Cancer Medicine