Difference between revisions of "Daratumumab (Darzalex)"

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==History of changes in FDA indication==
 
==History of changes in FDA indication==
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*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>
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*11/16/2015: [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]] or who are double-refractory to a PI and an immunomodulatory agent. ''(Based on SIRIUS)''
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*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)''
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*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]] who have received at least one prior therapy. ''(Label extended to second-line setting; based on CASTOR and POLLUX)''
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*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)''
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*6/16/2017: 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)''
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*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)''
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*5/7/2018: 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)''
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*8/20/2020: 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.
+
*6/27/2019: 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)''
 +
*9/26/2019: 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)''
 +
*8/20/2020: 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 and EQUULEUS)''
  
 
==Also known as==
 
==Also known as==
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[[Category:FDA approved in 2015]]
 
[[Category:FDA approved in 2015]]
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[[Category:Janssen Biotech product]]

Revision as of 01:12, 9 May 2021

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

  • 11/16/2015: 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 or who are double-refractory to a PI and an immunomodulatory agent. (Based on SIRIUS)
  • 11/21/2016: Approved 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)
  • 6/16/2017: 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)
  • 5/7/2018: 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)
  • 6/27/2019: 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)
  • 9/26/2019: 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)
  • 8/20/2020: 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 and EQUULEUS)

Also known as

  • Code name: JNJ-54767414
  • Brand names: Darzalex, HuMax-CD38

References

  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)
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