Difference between revisions of "Denosumab (Xgeva)"
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==General information== | ==General information== | ||
| − | Class/mechanism: Human IgG2 monoclonal antibody that inhibits RANK ligand (RANKL). | + | Class/mechanism: Human IgG2 monoclonal antibody that inhibits RANK ligand (RANKL). RANKL promotes the formation, function, and survival of osteoclasts, which are responsible for bone resorption.<ref name="insert">[http://pi.amgen.com/united_states/xgeva/xgeva_pi.pdf Denosumab (Xgeva) package insert]</ref><ref>[[:File:Denosumab.pdf | Denosumab (Xgeva) package insert (locally hosted backup)]]</ref><ref>[http://www.xgeva.com/ Xgeva manufacturer's website]</ref><ref>[http://www.prolia.com/ Prolia manufacturer's website]</ref> |
<br>Route: IV | <br>Route: IV | ||
<br>Extravasation: no information | <br>Extravasation: no information | ||
| Line 7: | Line 7: | ||
==Disease-specific information== | ==Disease-specific information== | ||
''For now this will be a gathering point for RCTs examining the use of this agent, which does not have clear antineoplastic properties with the exception of giant cell tumor of bone; in the future this information may be moved to separate page(s).'' | ''For now this will be a gathering point for RCTs examining the use of this agent, which does not have clear antineoplastic properties with the exception of giant cell tumor of bone; in the future this information may be moved to separate page(s).'' | ||
| + | |||
| + | *'''Amgen 20050244:''' Henry DH, Costa L, Goldwasser F, Hirsh V, Hungria V, Prausova J, Scagliotti GV, Sleeboom H, Spencer A, Vadhan-Raj S, von Moos R, Willenbacher W, Woll PJ, Wang J, Jiang Q, Jun S, Dansey R, Yeh H. Randomized, double-blind study of denosumab versus zoledronic acid in the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma. J Clin Oncol. 2011 Mar 20;29(9):1125-32. Epub 2011 Feb 22. [https://doi.org/10.1200/jco.2010.31.3304 link to original article] [https://pubmed.ncbi.nlm.nih.gov/21343556/ PubMed] [https://clinicaltrials.gov/study/NCT00330759 NCT00330759] | ||
| + | |||
| + | ===[[Breast cancer]]=== | ||
| + | *'''Amgen 20050136:''' Stopeck AT, Lipton A, Body JJ, Steger GG, Tonkin K, de Boer RH, Lichinitser M, Fujiwara Y, Yardley DA, Viniegra M, Fan M, Jiang Q, Dansey R, Jun S, Braun A. Denosumab compared with zoledronic acid for the treatment of bone metastases in patients with advanced breast cancer: a randomized, double-blind study. J Clin Oncol. 2010 Dec 10;28(35):5132-9. Epub 2010 Nov 8. [https://doi.org/10.1200/jco.2010.29.7101 link to original article] [https://pubmed.ncbi.nlm.nih.gov/21060033/ PubMed] [https://clinicaltrials.gov/study/NCT00321464 NCT00321464] | ||
| + | |||
| + | ===[[Multiple myeloma]]=== | ||
| + | *'''Amgen 20090482:''' Raje N, Terpos E, Willenbacher W, Shimizu K, García-Sanz R, Durie B, Legieć W, Krejčí M, Laribi K, Zhu L, Cheng P, Warner D, Roodman GD. Denosumab versus zoledronic acid in bone disease treatment of newly diagnosed multiple myeloma: an international, double-blind, double-dummy, randomised, controlled, phase 3 study. Lancet Oncol. 2018 Mar;19(3):370-381. Epub 2018 Feb 9. [https://doi.org/10.1016/s1470-2045(18)30072-x link to original article] [https://pubmed.ncbi.nlm.nih.gov/29429912/ PubMed] [https://clinicaltrials.gov/study/NCT01345019 NCT01345019] | ||
| + | |||
===[[Prostate cancer]]=== | ===[[Prostate cancer]]=== | ||
| − | *Fizazi K, Carducci M, Smith M, Damião R, Brown J, Karsh L, Milecki P, Shore N, Rader M, Wang H, Jiang Q, Tadros S, Dansey R, Goessl C. Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomised, double-blind study. Lancet. 2011 Mar 5;377(9768):813-22. Epub 2011 Feb 25. [https:// | + | *'''Amgen 20050103:''' Fizazi K, Carducci M, Smith M, Damião R, Brown J, Karsh L, Milecki P, Shore N, Rader M, Wang H, Jiang Q, Tadros S, Dansey R, Goessl C. Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomised, double-blind study. Lancet. 2011 Mar 5;377(9768):813-22. Epub 2011 Feb 25. [https://doi.org/10.1016/S0140-6736(10)62344-6 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3090685/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/21353695/ PubMed] [https://clinicaltrials.gov/study/NCT00321620 NCT00321620] |
| − | *Smith MR, Saad F, Coleman R, Shore N, Fizazi K, Tombal B, Miller K, Sieber P, Karsh L, Damião R, Tammela TL, Egerdie B, Van Poppel H, Chin J, Morote J, Gómez-Veiga F, Borkowski T, Ye Z, Kupic A, Dansey R, Goessl C. Denosumab and bone-metastasis-free survival in men with castration-resistant prostate cancer: results of a phase 3, randomised, placebo-controlled trial. Lancet. 2012 Jan 7;379(9810):39-46. Epub 2011 Nov 15. [https:// | + | *'''Amgen 20050147:''' Smith MR, Saad F, Coleman R, Shore N, Fizazi K, Tombal B, Miller K, Sieber P, Karsh L, Damião R, Tammela TL, Egerdie B, Van Poppel H, Chin J, Morote J, Gómez-Veiga F, Borkowski T, Ye Z, Kupic A, Dansey R, Goessl C. Denosumab and bone-metastasis-free survival in men with castration-resistant prostate cancer: results of a phase 3, randomised, placebo-controlled trial. Lancet. 2012 Jan 7;379(9810):39-46. Epub 2011 Nov 15. [https://doi.org/10.1016/S0140-6736(11)61226-9 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3671878/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/22093187/ PubMed] [https://clinicaltrials.gov/study/NCT00286091 NCT00286091] |
==Diseases for which it is used== | ==Diseases for which it is used== | ||
| − | *[[ | + | *[[Giant-cell tumor of bone]] |
==Patient drug information== | ==Patient drug information== | ||
| − | *[ | + | *[https://chemocare.com/druginfo/denosumab.aspx Denosumab (Xgeva) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/denosumab.aspx Denosumab (Xgeva) patient drug information (Chemocare)]</ref> |
*Brief patient counseling information can be found on [http://pi.amgen.com/united_states/xgeva/xgeva_pi.pdf#page=15 page 15 of the Denosumab (Xgeva) package insert]<ref name="insert"></ref> | *Brief patient counseling information can be found on [http://pi.amgen.com/united_states/xgeva/xgeva_pi.pdf#page=15 page 15 of the Denosumab (Xgeva) package insert]<ref name="insert"></ref> | ||
*[http://www.uptodate.com/contents/denosumab-patient-drug-information Denosumab (Xgeva) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/denosumab-patient-drug-information Denosumab (Xgeva) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/denosumab-patient-drug-information Denosumab (Xgeva) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/denosumab-patient-drug-information Denosumab (Xgeva) patient drug information (UpToDate)]</ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2010-06-01: Approved (as Prolia) for treatment of postmenopausal women with osteoporosis at high risk for fracture.<ref>[http://pi.amgen.com/united_states/prolia/prolia_pi.pdf Denosumab (Prolia) package insert]</ref> |
| − | *11 | + | *2010-11-18: Approved for prevention of skeletal-related events in patients with bone metastases from solid tumors.<ref name="insert"></ref> |
| − | * | + | *2013-06-13: Approved for treatment of adults and skeletally mature adolescents with [[Giant-cell tumor of bone | giant cell tumor of bone]] that is unresectable or where surgical resection is likely to result in severe morbidity. ''(Based on Amgen 20040215 & Amgen 20062004)'' |
| + | ==History of changes in EMA indication== | ||
| + | *2010-05-26: Initial authorization as Prolia | ||
| + | *2011-07-13: Initial authorization as Xgeva | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2011-05-10: Initial notice of compliance | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2012-01-18: Initial approval for the treatment of bone lesions due to multiple myeloma and bone lesions due to bone metastasis of solid tumor. | ||
| + | *2014-05-23: New additional indication and a new dosage for the treatment of [[Giant-cell tumor of bone | giant cell tumor of bone]]. | ||
==Also known as== | ==Also known as== | ||
| − | *'''Brand names:''' Prolia, Xgeva | + | *'''Brand names:''' Prolia, Ranmark, Xgeva |
==References== | ==References== | ||
| Line 32: | Line 49: | ||
[[Category:Drugs]] | [[Category:Drugs]] | ||
[[Category:Intravenous medications]] | [[Category:Intravenous medications]] | ||
| − | + | ||
[[Category:Anti-RANKL antibodies]] | [[Category:Anti-RANKL antibodies]] | ||
[[Category:RANK ligand inhibitors]] | [[Category:RANK ligand inhibitors]] | ||
| − | |||
| + | [[Category:Giant-cell tumor of bone medications]] | ||
| + | |||
| + | [[Category:EMA approved in 2010]] | ||
[[Category:FDA approved in 2010]] | [[Category:FDA approved in 2010]] | ||
| + | [[Category:Health Canada approved in 2011]] | ||
| + | [[Category:PMDA approved in 2012]] | ||
Revision as of 20:47, 28 May 2024
General information
Class/mechanism: Human IgG2 monoclonal antibody that inhibits RANK ligand (RANKL). RANKL promotes the formation, function, and survival of osteoclasts, which are responsible for bone resorption.[1][2][3][4]
Route: IV
Extravasation: no information
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]
Disease-specific information
For now this will be a gathering point for RCTs examining the use of this agent, which does not have clear antineoplastic properties with the exception of giant cell tumor of bone; in the future this information may be moved to separate page(s).
- Amgen 20050244: Henry DH, Costa L, Goldwasser F, Hirsh V, Hungria V, Prausova J, Scagliotti GV, Sleeboom H, Spencer A, Vadhan-Raj S, von Moos R, Willenbacher W, Woll PJ, Wang J, Jiang Q, Jun S, Dansey R, Yeh H. Randomized, double-blind study of denosumab versus zoledronic acid in the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma. J Clin Oncol. 2011 Mar 20;29(9):1125-32. Epub 2011 Feb 22. link to original article PubMed NCT00330759
Breast cancer
- Amgen 20050136: Stopeck AT, Lipton A, Body JJ, Steger GG, Tonkin K, de Boer RH, Lichinitser M, Fujiwara Y, Yardley DA, Viniegra M, Fan M, Jiang Q, Dansey R, Jun S, Braun A. Denosumab compared with zoledronic acid for the treatment of bone metastases in patients with advanced breast cancer: a randomized, double-blind study. J Clin Oncol. 2010 Dec 10;28(35):5132-9. Epub 2010 Nov 8. link to original article PubMed NCT00321464
Multiple myeloma
- Amgen 20090482: Raje N, Terpos E, Willenbacher W, Shimizu K, García-Sanz R, Durie B, Legieć W, Krejčí M, Laribi K, Zhu L, Cheng P, Warner D, Roodman GD. Denosumab versus zoledronic acid in bone disease treatment of newly diagnosed multiple myeloma: an international, double-blind, double-dummy, randomised, controlled, phase 3 study. Lancet Oncol. 2018 Mar;19(3):370-381. Epub 2018 Feb 9. link to original article PubMed NCT01345019
Prostate cancer
- Amgen 20050103: Fizazi K, Carducci M, Smith M, Damião R, Brown J, Karsh L, Milecki P, Shore N, Rader M, Wang H, Jiang Q, Tadros S, Dansey R, Goessl C. Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomised, double-blind study. Lancet. 2011 Mar 5;377(9768):813-22. Epub 2011 Feb 25. link to original article link to PMC article PubMed NCT00321620
- Amgen 20050147: Smith MR, Saad F, Coleman R, Shore N, Fizazi K, Tombal B, Miller K, Sieber P, Karsh L, Damião R, Tammela TL, Egerdie B, Van Poppel H, Chin J, Morote J, Gómez-Veiga F, Borkowski T, Ye Z, Kupic A, Dansey R, Goessl C. Denosumab and bone-metastasis-free survival in men with castration-resistant prostate cancer: results of a phase 3, randomised, placebo-controlled trial. Lancet. 2012 Jan 7;379(9810):39-46. Epub 2011 Nov 15. link to original article link to PMC article PubMed NCT00286091
Diseases for which it is used
Patient drug information
- Denosumab (Xgeva) patient drug information (Chemocare)[5]
- Brief patient counseling information can be found on page 15 of the Denosumab (Xgeva) package insert[1]
- Denosumab (Xgeva) patient drug information (UpToDate)[6]
History of changes in FDA indication
- 2010-06-01: Approved (as Prolia) for treatment of postmenopausal women with osteoporosis at high risk for fracture.[7]
- 2010-11-18: Approved for prevention of skeletal-related events in patients with bone metastases from solid tumors.[1]
- 2013-06-13: Approved for treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. (Based on Amgen 20040215 & Amgen 20062004)
History of changes in EMA indication
- 2010-05-26: Initial authorization as Prolia
- 2011-07-13: Initial authorization as Xgeva
History of changes in Health Canada indication
- 2011-05-10: Initial notice of compliance
History of changes in PMDA indication
- 2012-01-18: Initial approval for the treatment of bone lesions due to multiple myeloma and bone lesions due to bone metastasis of solid tumor.
- 2014-05-23: New additional indication and a new dosage for the treatment of giant cell tumor of bone.
Also known as
- Brand names: Prolia, Ranmark, Xgeva
References
- ↑ 1.0 1.1 1.2 1.3 Denosumab (Xgeva) package insert
- ↑ Denosumab (Xgeva) package insert (locally hosted backup)
- ↑ Xgeva manufacturer's website
- ↑ Prolia manufacturer's website
- ↑ Denosumab (Xgeva) patient drug information (Chemocare)
- ↑ Denosumab (Xgeva) patient drug information (UpToDate)
- ↑ Denosumab (Prolia) package insert