Difference between revisions of "Enzalutamide (Xtandi)"
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==General information== | ==General information== | ||
| − | Class/mechanism: Antiandrogen; androgen receptor inhibitor (ARI) or androgen receptor signaling inhibitor (ARSI). | + | Class/mechanism: Antiandrogen; androgen receptor inhibitor (ARI) or androgen receptor signaling inhibitor (ARSI). Enzalutamide competitively inhibits testosterone from binding to the androgen receptor, interferes with translocation of the androgen receptor to the nucleus, and inhibits binding to DNA, resulting in decreased prostate cancer proliferation and cell death.<ref name="insert">[http://www.astellas.us/docs/us/12A005-ENZ-WPI.pdf Enzalutamide (Xtandi) package insert]</ref><ref>[[:File:Enzalutamide.pdf | Enzalutamide (Xtandi) package insert (locally hosted backup)]]</ref><ref>[http://xtandi.com/ Xtandi manufacturer's website]</ref> |
<br>Route: PO | <br>Route: PO | ||
<br>Extravasation: n/a | <br>Extravasation: n/a | ||
| Line 12: | Line 12: | ||
==Patient drug information== | ==Patient drug information== | ||
*[http://www.astellas.us/docs/us/12A005-ENZ-WPI.pdf Enzalutamide (Xtandi) package insert]<ref name="insert"></ref> | *[http://www.astellas.us/docs/us/12A005-ENZ-WPI.pdf Enzalutamide (Xtandi) package insert]<ref name="insert"></ref> | ||
| − | *[ | + | *[https://chemocare.com/druginfo/enzalutamide.aspx Enzalutamide (Xtandi) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/enzalutamide.aspx Enzalutamide (Xtandi) patient drug information (Chemocare)]</ref> |
*[http://www.uptodate.com/contents/enzalutamide-patient-drug-information Enzalutamide (Xtandi) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/enzalutamide-patient-drug-information Enzalutamide (Xtandi) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/enzalutamide-patient-drug-information Enzalutamide (Xtandi) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/enzalutamide-patient-drug-information Enzalutamide (Xtandi) patient drug information (UpToDate)]</ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2012-08-31: [http://www.fda.gov/drugs/informationondrugs/approveddrugs/ucm317997.htm Initial approval] for the treatment of patients with metastatic castration-resistant [[prostate cancer]] who have previously received [[Docetaxel (Taxotere)|docetaxel]]. ''(Based on AFFIRM)'' |
| − | * | + | *2014-09-10: Approved for the treatment of patients with metastatic castration-resistant [[prostate cancer]] (mCRPC). ''(No longer needs to be after docetaxel; based on PREVAIL and TERRAIN)'' |
| − | * | + | *2018-07-13: Approved for patients with [[Prostate cancer|castration-resistant prostate cancer (CRPC)]]. ''(No longer needs to be metatstatic; based on PROSPER<sub>PrCA</sub>)'' |
| − | *12 | + | *2019-12-16: Approved for patients with metastatic castration-sensitive [[prostate cancer]] (mCSPC). ''(No longer needs to be castration-resistant, if metastatic; based on ARCHES)'' |
| + | *2023-11-16: Approved for non-metastatic castration-sensitive [[prostate cancer]] (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). ''(No longer needs to be castration-resistant; based on EMBARK)'' | ||
| + | ==History of changes in EMA indication== | ||
| + | *2013-06-21: Initial marketing authorization as Xtandi. Xtandi is indicated for the treatment of adult men with metastatic castration-resistant [[prostate cancer]] whose disease has progressed on or after docetaxel therapy. ''(Based on AFFIRM)'' | ||
| + | *2014-11-28: Extension of indication for the treatment of adult men with metastatic castration-resistant [[prostate cancer]] who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. | ||
| + | *2018-10-23: Extension of Indication to include adult men with high-risk non-metastatic castration-resistant [[prostate cancer]] (CRPC). | ||
| + | *2021-04-30: Extension of Indication to include the treatment of adult men with metastatic hormonesensitive [[prostate cancer]] (mHSPC) for Xtandi in combination with androgen deprivation therapy. ''(Based on ARCHES)'' | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2013-05-29: Initial notice of compliance | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2014-03-24: Initial approval for the treatment of castration-resistant [[prostate cancer]]. | ||
| + | *2020-05-29: New indication for the treatment of metastatic [[prostate cancer]]. | ||
==Also known as== | ==Also known as== | ||
| − | *'''Code name:''' | + | *'''Code name:''' MDV-3100 |
| − | *'''Brand names:''' Azel, Bdenza, Capmide, Enzamide, Glenza, Indenza, Xtandi | + | *'''Brand names:''' Azel, Bdenza, Bnyx, Capmide, Enzamide, Glenza, Indenza, Xtandi |
==References== | ==References== | ||
| Line 31: | Line 42: | ||
[[Category:Oral medications]] | [[Category:Oral medications]] | ||
| − | [[Category: | + | [[Category:Second-generation nonsteroidal antiandrogens]] |
[[Category:Breast cancer medications]] | [[Category:Breast cancer medications]] | ||
[[Category:Prostate cancer medications]] | [[Category:Prostate cancer medications]] | ||
| + | |||
| + | [[Category:EMA approved in 2013]] | ||
[[Category:FDA approved in 2012]] | [[Category:FDA approved in 2012]] | ||
| + | [[Category:Health Canada approved in 2013]] | ||
| + | [[Category:PMDA approved in 2014]] | ||
| + | [[Category:WHO Essential Cancer Medicine]] | ||
Revision as of 18:20, 22 March 2024
General information
Class/mechanism: Antiandrogen; androgen receptor inhibitor (ARI) or androgen receptor signaling inhibitor (ARSI). Enzalutamide competitively inhibits testosterone from binding to the androgen receptor, interferes with translocation of the androgen receptor to the nucleus, and inhibits binding to DNA, resulting in decreased prostate cancer proliferation and cell death.[1][2][3]
Route: PO
Extravasation: n/a
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.
Diseases for which it is used
Patient drug information
- Enzalutamide (Xtandi) package insert[1]
- Enzalutamide (Xtandi) patient drug information (Chemocare)[4]
- Enzalutamide (Xtandi) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 2012-08-31: Initial approval for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. (Based on AFFIRM)
- 2014-09-10: Approved for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). (No longer needs to be after docetaxel; based on PREVAIL and TERRAIN)
- 2018-07-13: Approved for patients with castration-resistant prostate cancer (CRPC). (No longer needs to be metatstatic; based on PROSPERPrCA)
- 2019-12-16: Approved for patients with metastatic castration-sensitive prostate cancer (mCSPC). (No longer needs to be castration-resistant, if metastatic; based on ARCHES)
- 2023-11-16: Approved for non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). (No longer needs to be castration-resistant; based on EMBARK)
History of changes in EMA indication
- 2013-06-21: Initial marketing authorization as Xtandi. Xtandi is indicated for the treatment of adult men with metastatic castration-resistant prostate cancer whose disease has progressed on or after docetaxel therapy. (Based on AFFIRM)
- 2014-11-28: Extension of indication for the treatment of adult men with metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.
- 2018-10-23: Extension of Indication to include adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC).
- 2021-04-30: Extension of Indication to include the treatment of adult men with metastatic hormonesensitive prostate cancer (mHSPC) for Xtandi in combination with androgen deprivation therapy. (Based on ARCHES)
History of changes in Health Canada indication
- 2013-05-29: Initial notice of compliance
History of changes in PMDA indication
- 2014-03-24: Initial approval for the treatment of castration-resistant prostate cancer.
- 2020-05-29: New indication for the treatment of metastatic prostate cancer.
Also known as
- Code name: MDV-3100
- Brand names: Azel, Bdenza, Bnyx, Capmide, Enzamide, Glenza, Indenza, Xtandi