Difference between revisions of "Daratumumab (Darzalex)"
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==General information== | ==General information== | ||
| − | Class/mechanism: Anti-CD38 antibody, human monoclonal IgG1 kappa. | + | Class/mechanism: Anti-CD38 antibody, human monoclonal IgG1 kappa. Daratumumab binds to CD38 and causes apoptosis in CD38-expressing cells via Fc mediated cross-linking, complement-dependent cytotoxicity (CDC), antibody-dependent cell mediated cytotoxicity (ADCC), and antibody dependent cellular phagocytosis (ADCP). CD38 is present on the cell surface of multiple myeloma (MM), plasma leukemia, and natural killer (NK) cells.<ref name=insert>[https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX-pi.pdf Daratumumab (Darzalex) package insert]</ref><ref>[[:File:Daratumumab.pdf|Daratumumab (Darzalex) package insert (locally hosted backup)]]</ref><ref>[http://www.cancer.gov/publications/dictionaries/cancer-drug?CdrID=583564 Daratumumab page at NCI Drug Dictionary]</ref><ref>[http://www.darzalex.com/ Darzalex manufacturer's website]</ref> |
<br>Route: IV | <br>Route: IV | ||
<br>Extravasation: no information | <br>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. | + | 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 used== | ==Diseases for which it is used== | ||
| + | *[[Light-chain (AL) amyloidosis]] | ||
*[[Multiple myeloma]] | *[[Multiple myeloma]] | ||
==Patient drug information== | ==Patient drug information== | ||
| − | *[ | + | *[https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX-pi.pdf Daratumumab (Darzalex) package insert]<ref name="insert"></ref> |
| + | *[https://chemocare.com/druginfo/daratumumab.aspx Daratumumab (Darzalex) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/daratumumab.aspx Daratumumab (Darzalex) patient drug information (Chemocare)]</ref> | ||
| + | *[http://www.uptodate.com/contents/daratumumab-patient-drug-information Daratumumab (Darzalex) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/daratumumab-patient-drug-information Daratumumab (Darzalex) patient drug information (UpToDate)]</ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *11 | + | *2015-11-16: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm472904.htm Granted accelerated approval] for the treatment of patients with [[multiple myeloma]] who have received at least three prior lines of therapy including a [[:Category:Proteasome inhibitors | proteasome inhibitor (PI)]] and an [[:Category:Immunomodulatory drugs (IMiDs) | immunomodulatory agent]]. ''(Based on GEN501 part 2 & SIRIUS)'' |
| + | *2015-11-16: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm472904.htm Granted accelerated approval] for the treatment of patients with [[multiple myeloma]] who are double-refractory to a PI and an immunomodulatory agent. ''(Based on GEN501 part 2 & SIRIUS)'' | ||
| + | *2016-11-21: Full approval in combination with [[Lenalidomide (Revlimid)|lenalidomide]] and [[Dexamethasone (Decadron)|dexamethasone]], or [[Bortezomib (Velcade)|bortezomib]] and [[Dexamethasone (Decadron)|dexamethasone]], for the treatment of patients with [[multiple myeloma]] who have received at least one prior therapy. ''(Label extended to second-line setting; based on CASTOR and POLLUX)'' | ||
| + | *2017-06-16: Approved in combination with pomalidomide and dexamethasone for the treatment of patients with [[multiple myeloma]] who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. ''(Based on EQUULEUS<sub>pom</sub>)'' | ||
| + | *2018-05-07: Approved in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed [[multiple myeloma]] who are ineligible for autologous stem cell transplant. ''(Based on ALCYONE)'' | ||
| + | *2019-06-27: Approved in combination with lenalidomide and dexamethasone for patients with newly diagnosed [[multiple myeloma]] who are ineligible for autologous stem cell transplant. ''(Label extended to first-line transplant-ineligible setting; based on MAIA)'' | ||
| + | *2019-09-26: Approved for adult patients with [[multiple myeloma]] in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant (ASCT). ''(Label extended to first-line transplant-eligible setting; based on CASSIOPEIA part 1)'' | ||
| + | *2020-08-20: Approved in combination with [[Carfilzomib (Kyprolis)|carfilzomib]] and [[Dexamethasone (Decadron)|dexamethasone]] for adult patients with relapsed or refractory [[multiple myeloma]] who have received one to three lines of therapy. ''(Based on CANDOR)'' | ||
| + | ==History of changes in EMA indication== | ||
| + | *2016-05-20: Initial authorization | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2016-06-29: Initial notice of compliance with conditions | ||
| + | *2018-10-10: Conditions were met | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2017-09-27: New approval for the treatment of relapsed or refractory [[multiple myeloma]]. | ||
| + | *2019-08-22: New indication and a new dosage for the treatment of [[multiple myeloma]]. | ||
==Also known as== | ==Also known as== | ||
| − | + | *'''Code name:''' JNJ-54767414 | |
| + | *'''Generic name:''' daratumumab-fihj | ||
| + | *'''Brand names:''' Darzalex, HuMax-CD38 | ||
==References== | ==References== | ||
<references/> | <references/> | ||
| − | [[Category: | + | [[Category:Drugs]] |
| − | + | [[Category:Intravenous medications]] | |
| − | [[Category:Intravenous | ||
[[Category:Anti-CD38 antibodies]] | [[Category:Anti-CD38 antibodies]] | ||
| − | [[Category: | + | |
| + | [[Category:Light-chain (AL) amyloidosis medications]] | ||
[[Category:Multiple myeloma medications]] | [[Category:Multiple myeloma medications]] | ||
| − | [[Category: | + | [[Category:FDA approved in 2015]] |
| + | [[Category:EMA approved in 2016]] | ||
| + | [[Category:Health Canada approved in 2016]] | ||
| + | [[Category:PMDA approved in 2017]] | ||
| + | |||
| + | [[Category:Janssen Biotech product]] | ||
Latest revision as of 13:49, 9 February 2024
General information
Class/mechanism: Anti-CD38 antibody, human monoclonal IgG1 kappa. Daratumumab binds to CD38 and causes apoptosis in CD38-expressing cells via Fc mediated cross-linking, complement-dependent cytotoxicity (CDC), antibody-dependent cell mediated cytotoxicity (ADCC), and antibody dependent cellular phagocytosis (ADCP). CD38 is present on the cell surface of multiple myeloma (MM), plasma leukemia, and natural killer (NK) cells.[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]
Diseases for which it is used
Patient drug information
- Daratumumab (Darzalex) package insert[1]
- Daratumumab (Darzalex) patient drug information (Chemocare)[5]
- Daratumumab (Darzalex) patient drug information (UpToDate)[6]
History of changes in FDA indication
- 2015-11-16: Granted accelerated approval for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent. (Based on GEN501 part 2 & SIRIUS)
- 2015-11-16: Granted accelerated approval for the treatment of patients with multiple myeloma who are double-refractory to a PI and an immunomodulatory agent. (Based on GEN501 part 2 & SIRIUS)
- 2016-11-21: Full approval in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. (Label extended to second-line setting; based on CASTOR and POLLUX)
- 2017-06-16: Approved in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. (Based on EQUULEUSpom)
- 2018-05-07: Approved in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. (Based on ALCYONE)
- 2019-06-27: Approved in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. (Label extended to first-line transplant-ineligible setting; based on MAIA)
- 2019-09-26: Approved for adult patients with multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant (ASCT). (Label extended to first-line transplant-eligible setting; based on CASSIOPEIA part 1)
- 2020-08-20: Approved in combination with carfilzomib and dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. (Based on CANDOR)
History of changes in EMA indication
- 2016-05-20: Initial authorization
History of changes in Health Canada indication
- 2016-06-29: Initial notice of compliance with conditions
- 2018-10-10: Conditions were met
History of changes in PMDA indication
- 2017-09-27: New approval for the treatment of relapsed or refractory multiple myeloma.
- 2019-08-22: New indication and a new dosage for the treatment of multiple myeloma.
Also known as
- Code name: JNJ-54767414
- Generic name: daratumumab-fihj
- Brand names: Darzalex, HuMax-CD38
References
- ↑ 1.0 1.1 1.2 Daratumumab (Darzalex) package insert
- ↑ Daratumumab (Darzalex) package insert (locally hosted backup)
- ↑ Daratumumab page at NCI Drug Dictionary
- ↑ Darzalex manufacturer's website
- ↑ Daratumumab (Darzalex) patient drug information (Chemocare)
- ↑ Daratumumab (Darzalex) patient drug information (UpToDate)