Difference between revisions of "Daratumumab (Darzalex)"

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

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 EQUULEUS_pom)
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

[insert-1] 1.0 ^1.1 ^1.2 Daratumumab (Darzalex) package insert

[2] Daratumumab (Darzalex) package insert (locally hosted backup)

[3] Daratumumab page at NCI Drug Dictionary

[4] Darzalex manufacturer's website

[5] Daratumumab (Darzalex) patient drug information (Chemocare)

[6] Daratumumab (Darzalex) patient drug information (UpToDate)

[1]

[2]

[3]

[4]

[5]

[6]

@@ Line 1: / Line 1: @@
 ==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.<ref name=insert>[http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX-pi.pdf Daratumumab (Darzalex) package insert]</ref><ref>[[Media: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>
+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>Extravasation: no information
@@ Line 11: / Line 11: @@
 ==Patient drug information==
-*[http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX-pi.pdf Daratumumab (Darzalex) package insert]<ref name="insert"></ref>
+*[https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX-pi.pdf Daratumumab (Darzalex) package insert]<ref name="insert"></ref>
-*[http://www.chemocare.com/chemotherapy/drug-info/daratumumab.aspx Daratumumab (Darzalex) patient drug information (Chemocare)]<ref>[http://www.chemocare.com/chemotherapy/drug-info/daratumumab.aspx Daratumumab (Darzalex) patient drug information (Chemocare)]</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==
-*11/16/2015: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm472904.htm Granted accelerated approval] for the treatment of patients with [[Multiple_myeloma,_relapsed-refractory|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]] or who are double-refractory to a PI and an immunomodulatory agent.<ref name="insert"></ref>
+*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)''
-*11/21/2016: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm530249.htm Approved] 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,_relapsed-refractory|multiple myeloma who have received at least one prior therapy]]. ''(Label extended to second-line setting)''
+*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)''
-*6/27/2019: Approved in combination with lenalidomide and dexamethasone for patients with [[Multiple_myeloma,_induction|newly diagnosed multiple myeloma]] who are ineligible for autologous stem cell transplant. ''(Label extended to first-line transplant-ineligible setting)''
+*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)''
-*9/26/2019: Approved for adult patients with [[Multiple_myeloma,_induction|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)''
+*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==
 *'''Code name:''' JNJ-54767414
+*'''Generic name:''' daratumumab-fihj
 *'''Brand names:''' Darzalex, HuMax-CD38
@@ Line 30: / Line 43: @@
 [[Category:Drugs]]
 [[Category:Intravenous medications]]
 [[Category:Anti-CD38 antibodies]]
@@ Line 38: / Line 50: @@
 [[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]]