Difference between revisions of "Darolutamide (Nubeqa)"
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==General information== | ==General information== | ||
| − | Class/mechanism: Antiandrogen; non-steroidal androgen receptor inhibitor, non-steroidal antiandrogen (NSAA) that competitively inhibits androgens by binding to androgen receptors and exhibiting antitumor activity by blocking testosterone-induced nuclear translocation of androgen receptors.<ref>Moilanen AM, Riikonen R, Oksala R, Ravanti L, Aho E, Wohlfahrt G, Nykänen PS, Törmäkangas OP, Palvimo JJ, Kallio PJ. Discovery of ODM-201, a new-generation androgen receptor inhibitor targeting resistance mechanisms to androgen signaling-directed prostate cancer therapies. Sci Rep. 2015 Jul 3;5:12007. [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4490394/ link to original article] [https://pubmed.ncbi.nlm.nih.gov/26137992 PubMed]</ref> | + | Class/mechanism: Antiandrogen; non-steroidal androgen receptor inhibitor, non-steroidal antiandrogen (NSAA) that competitively inhibits androgens by binding to androgen receptors and exhibiting antitumor activity by blocking testosterone-induced nuclear translocation of androgen receptors.<ref name="insert">[http://labeling.bayerhealthcare.com/html/products/pi/Nubeqa_PI.pdf Darolutamide (Nubeqa) package insert]</ref><ref>[[:File:Darolutamide.pdf | Darolutamide (Nubeqa) package insert (locally hosted backup)]]</ref><ref>[https://www.nubeqa-us.com/ Nubeqa manufacturer's website]</ref><ref>Moilanen AM, Riikonen R, Oksala R, Ravanti L, Aho E, Wohlfahrt G, Nykänen PS, Törmäkangas OP, Palvimo JJ, Kallio PJ. Discovery of ODM-201, a new-generation androgen receptor inhibitor targeting resistance mechanisms to androgen signaling-directed prostate cancer therapies. Sci Rep. 2015 Jul 3;5:12007. [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4490394/ link to original article] [https://pubmed.ncbi.nlm.nih.gov/26137992/ PubMed]</ref> |
<br>Route: PO | <br>Route: PO | ||
<br>Extravasation: n/a | <br>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 | + | 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, [https://online.lexi.com/lco/action/login UpToDate Lexidrug], [http://reference.medscape.com/drug/casodex-bicalutamide-342210 Medscape] [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information. |
==Diseases for which it is used== | ==Diseases for which it is used== | ||
*[[Prostate cancer]] | *[[Prostate cancer]] | ||
| + | |||
| + | ==Patient drug information== | ||
| + | *[http://labeling.bayerhealthcare.com/html/products/pi/Nubeqa_PI.pdf Darolutamide (Nubeqa) package insert]<ref name="insert"></ref> | ||
| + | *[https://www.chemocare.com/druginfo/darolutamide.aspx Darolutamide (Nubeqa) patient drug information (Chemocare)]<ref>[https://www.chemocare.com/druginfo/darolutamide.aspx Darolutamide (Nubeqa) patient drug information (Chemocare)]</ref> | ||
| + | *[http://www.uptodate.com/contents/darolutamide-patient-drug-information Darolutamide (Nubeqa) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/darolutamide-patient-drug-information Darolutamide (Nubeqa) patient drug information (UpToDate)]</ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2019-07-30: Initial approval for non-metastatic castration-resistant [[prostate cancer]]. ''(Based on ARAMIS)'' |
| − | + | *2022-08-05: Approved in combination with docetaxel for adult patients with metastatic hormone-sensitive [[prostate cancer]] (mHSPC). ''(Based on ARASENS)'' | |
| + | ==History of changes in EMA indication== | ||
| + | *2020-03-27: Initial authorization as Nubeqa. Nubeqa is indicated for the treatment of adult men with non metastatic castration resistant [[prostate cancer]] (nmCRPC) who are at risk of developing metastatic disease. ''(Based on ARAMIS)'' | ||
| + | *2023-03-20: Additional indication for metastatic hormone sensitive [[prostate cancer]] (mHSPC) in combination with docetaxel and androgen deprivation therapy. ''(Based on ARASENS)'' | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2020-02-20: Notice of compliance for the treatment of patients with non-metastatic castration resistant [[prostate cancer]] (nmCRPC). | ||
| + | *2022-09-29: New indication (details unknown) | ||
| + | ==History of changes in PMDA indications== | ||
| + | *2020-01-23: Newly indicated for the treatment of non-metastatic, castration-resistant [[prostate cancer]]. | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' BAY-1841788, ODM-201 | *'''Code name:''' BAY-1841788, ODM-201 | ||
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[[Category:Drugs]] | [[Category:Drugs]] | ||
[[Category:Oral medications]] | [[Category:Oral medications]] | ||
| − | [[Category: | + | [[Category:Second-generation nonsteroidal antiandrogens]] |
[[Category:Prostate cancer medications]] | [[Category:Prostate cancer medications]] | ||
[[Category:FDA approved in 2019]] | [[Category:FDA approved in 2019]] | ||
| + | [[Category:EMA approved in 2020]] | ||
| + | [[Category:Health Canada approved in 2020]] | ||
| + | [[Category:PMDA approved in 2020]] | ||
Latest revision as of 01:47, 29 June 2024
General information
Class/mechanism: Antiandrogen; non-steroidal androgen receptor inhibitor, non-steroidal antiandrogen (NSAA) that competitively inhibits androgens by binding to androgen receptors and exhibiting antitumor activity by blocking testosterone-induced nuclear translocation of androgen receptors.[1][2][3][4]
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, UpToDate Lexidrug, Medscape UpToDate (courtesy of Lexicomp), or the prescribing information.
Diseases for which it is used
Patient drug information
- Darolutamide (Nubeqa) package insert[1]
- Darolutamide (Nubeqa) patient drug information (Chemocare)[5]
- Darolutamide (Nubeqa) patient drug information (UpToDate)[6]
History of changes in FDA indication
- 2019-07-30: Initial approval for non-metastatic castration-resistant prostate cancer. (Based on ARAMIS)
- 2022-08-05: Approved in combination with docetaxel for adult patients with metastatic hormone-sensitive prostate cancer (mHSPC). (Based on ARASENS)
History of changes in EMA indication
- 2020-03-27: Initial authorization as Nubeqa. Nubeqa is indicated for the treatment of adult men with non metastatic castration resistant prostate cancer (nmCRPC) who are at risk of developing metastatic disease. (Based on ARAMIS)
- 2023-03-20: Additional indication for metastatic hormone sensitive prostate cancer (mHSPC) in combination with docetaxel and androgen deprivation therapy. (Based on ARASENS)
History of changes in Health Canada indication
- 2020-02-20: Notice of compliance for the treatment of patients with non-metastatic castration resistant prostate cancer (nmCRPC).
- 2022-09-29: New indication (details unknown)
History of changes in PMDA indications
- 2020-01-23: Newly indicated for the treatment of non-metastatic, castration-resistant prostate cancer.
Also known as
- Code name: BAY-1841788, ODM-201
- Brand name: Nubeqa
References
- ↑ 1.0 1.1 Darolutamide (Nubeqa) package insert
- ↑ Darolutamide (Nubeqa) package insert (locally hosted backup)
- ↑ Nubeqa manufacturer's website
- ↑ Moilanen AM, Riikonen R, Oksala R, Ravanti L, Aho E, Wohlfahrt G, Nykänen PS, Törmäkangas OP, Palvimo JJ, Kallio PJ. Discovery of ODM-201, a new-generation androgen receptor inhibitor targeting resistance mechanisms to androgen signaling-directed prostate cancer therapies. Sci Rep. 2015 Jul 3;5:12007. link to original article PubMed
- ↑ Darolutamide (Nubeqa) patient drug information (Chemocare)
- ↑ Darolutamide (Nubeqa) patient drug information (UpToDate)