Difference between revisions of "Enzalutamide (Xtandi)"
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*8/31/2012: [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)'' | *8/31/2012: [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)'' | ||
*9/10/2014: 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)'' | *9/10/2014: 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)'' | ||
| − | *7/13/2018: Approved for patients with [[Prostate cancer|castration-resistant prostate cancer (CRPC)]]. ''(No longer needs to be metatstatic; based on PROSPER)'' | + | *7/13/2018: Approved for patients with [[Prostate cancer|castration-resistant prostate cancer (CRPC)]]. ''(No longer needs to be metatstatic; based on PROSPER<sub>PrCA</sub>)'' |
*12/16/2019: Approved for patients with [[Prostate cancer|metastatic castration-sensitive prostate cancer (mCSPC)]]. ''(No longer needs to be castration-resistant, if metastatic; based on ARCHES)'' | *12/16/2019: Approved for patients with [[Prostate cancer|metastatic castration-sensitive prostate cancer (mCSPC)]]. ''(No longer needs to be castration-resistant, if metastatic; based on ARCHES)'' | ||
Revision as of 13:35, 10 July 2022
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
- 8/31/2012: Initial approval for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. (Based on AFFIRM)
- 9/10/2014: 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)
- 7/13/2018: Approved for patients with castration-resistant prostate cancer (CRPC). (No longer needs to be metatstatic; based on PROSPERPrCA)
- 12/16/2019: Approved for patients with metastatic castration-sensitive prostate cancer (mCSPC). (No longer needs to be castration-resistant, if metastatic; based on ARCHES)
History of changes in EMA indication
- 6/21/2013: Initial marketing authorization as Xtandi
Also known as
- Code name: MDV3100
- Brand names: Azel, Bdenza, Bnyx, Capmide, Enzamide, Glenza, Indenza, Xtandi