Difference between revisions of "Daratumumab and hyaluronidase (Darzalex Faspro)"
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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">[http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX+Faspro-pi.pdf Daratumumab and hyaluronidase (Darzalex Faspro) package insert]</ref><ref>[[:File:Daratumumab_hyaluronidase-fihj.pdf | Daratumumab and hyaluronidase (Darzalex Faspro) package insert (locally hosted backup)]]</ref><ref>[https://www.darzalex.com/ Darzalex Faspro manufacturer's website]</ref> |
<br>Route: SC | <br>Route: SC | ||
| − | 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 | + | 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 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== | ||
| + | *[http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX+Faspro-pi.pdf Daratumumab and hyaluronidase (Darzalex Faspro) package insert]<ref name="insert"></ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | ===[[Light-chain (AL) amyloidosis]]=== |
| − | + | *2021-01-15: Accelerated approval in combination with bortezomib, cyclophosphamide and dexamethasone for newly diagnosed [[light-chain (AL) amyloidosis]]. ''(New disease entity; based on ANDROMEDA)'' | |
| − | * | + | ===[[Multiple myeloma]]=== |
| − | * | + | *2020-05-01: [https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-daratumumab-and-hyaluronidase-fihj-multiple-myeloma Approved] for adult patients with newly diagnosed or relapsed/refractory [[multiple myeloma]] in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant. ''(Based on PLEIADES)'' |
| − | * | + | *2020-05-01: Approved for adult patients with newly diagnosed or relapsed/refractory [[multiple myeloma]] in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy. ''(Based on PLEIADES)'' |
| + | *2020-05-01: Approved for adult patients with newly diagnosed or relapsed/refractory [[multiple myeloma]] in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy. ''(Based on COLUMBA)'' | ||
| + | *2020-05-01: Approved for adult patients with newly diagnosed or relapsed/refractory [[multiple myeloma]] as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent. ''(Based on COLUMBA)'' | ||
| + | *2021-07-09: Approved in combination with pomalidomide and dexamethasone for adult patients with [[multiple myeloma]] who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor. ''(Based on APOLLO)'' | ||
| + | *2021-11-30: Approved for adult patients with relapsed or refractory [[multiple myeloma]] who have received 1 to 3 prior lines of therapy. ''(Based on PLEIADES)'' | ||
==Also known as== | ==Also known as== | ||
*'''Generic name:''' daratumumab and hyaluronidase-fihj | *'''Generic name:''' daratumumab and hyaluronidase-fihj | ||
*'''Brand name:''' Darzalex Faspro | *'''Brand name:''' Darzalex Faspro | ||
| + | |||
| + | ==References== | ||
| + | <references/> | ||
[[Category:Drugs]] | [[Category:Drugs]] | ||
| Line 24: | Line 35: | ||
[[Category:Anti-CD38 antibodies]] | [[Category:Anti-CD38 antibodies]] | ||
| + | [[Category:Light-chain (AL) amyloidosis medications]] | ||
[[Category:Multiple myeloma medications]] | [[Category:Multiple myeloma medications]] | ||
[[Category:FDA approved in 2020]] | [[Category:FDA approved in 2020]] | ||
Latest revision as of 01:02, 29 June 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]
Route: SC
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 or the prescribing information.[1]
Diseases for which it is used
Patient drug information
History of changes in FDA indication
Light-chain (AL) amyloidosis
- 2021-01-15: Accelerated approval in combination with bortezomib, cyclophosphamide and dexamethasone for newly diagnosed light-chain (AL) amyloidosis. (New disease entity; based on ANDROMEDA)
Multiple myeloma
- 2020-05-01: Approved for adult patients with newly diagnosed or relapsed/refractory multiple myeloma in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant. (Based on PLEIADES)
- 2020-05-01: Approved for adult patients with newly diagnosed or relapsed/refractory multiple myeloma in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy. (Based on PLEIADES)
- 2020-05-01: Approved for adult patients with newly diagnosed or relapsed/refractory multiple myeloma in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy. (Based on COLUMBA)
- 2020-05-01: Approved for adult patients with newly diagnosed or relapsed/refractory multiple myeloma as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent. (Based on COLUMBA)
- 2021-07-09: Approved in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor. (Based on APOLLO)
- 2021-11-30: Approved for adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. (Based on PLEIADES)
Also known as
- Generic name: daratumumab and hyaluronidase-fihj
- Brand name: Darzalex Faspro