Difference between revisions of "Dinutuximab (Unituxin)"
Jump to navigation
Jump to search
m (→Also known as) |
Warner-admin (talk | contribs) m (Text replacement - "please refer to your preferred pharmacopeias such as [http://www.thomsonhc.com/home/dispatch Micromedex], [https://online.lexi.com/lco/action/login UpToDate Lexidrug], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information" to "please refer to your preferred pharmacopeias or the prescribing information") |
||
| (13 intermediate revisions by 3 users not shown) | |||
| Line 1: | Line 1: | ||
==Mechanism of action== | ==Mechanism of action== | ||
| − | From the [ | + | From the [https://www.cancer.gov/publications/dictionaries/cancer-drug?CdrID=42042 NCI drug dictionary]: A chimeric mouse/human monoclonal antibody with potential antineoplastic activity. Dinutuximab binds to the ganglioside GD2 and induces antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity against GD2-expressing tumor cells. |
<br>Route: IV | <br>Route: IV | ||
| − | 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 or the prescribing information. |
==Diseases for which it is used== | ==Diseases for which it is used== | ||
| Line 9: | Line 9: | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2015-03-10: Initial FDA approval in combination with [[Sargramostim (Leukine)|granulocyte-macrophage colony-stimulating factor (GM-CSF)]], [[Aldesleukin (Proleukin)|interleukin-2 (IL-2)]], and [[Isotretinoin (Accutane)|13-cis-retinoic acid (RA)]], for the treatment of pediatric patients with high-risk [[Neuroblastoma|neuroblastoma]] who achieve at least a partial response to prior first-line multiagent, multimodality therapy. ''(Based on COG ANBL0032)'' |
| + | ==History of changes in EMA indication== | ||
| + | *2015-08-14: Initial authorization for the treatment of high risk [[neuroblastoma]]. | ||
| + | *2017-03-20: Authorization withdrawn at the request of the manufacturer, for supply chain reasons | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2018-11-29: Initial notice of compliance | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2021-06-23: Initial approval for the treatment of [[neuroblastoma]] following high-dose chemotherapy. | ||
| + | |||
| + | ==Patient Drug Information== | ||
| + | *[https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125516s000lbl.pdf Dinutuximab (Unituxin) Package Insert]<ref>[https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125516s000lbl.pdf Dinutuximab (Unituxin) Package Insert]</ref> | ||
==Also known as== | ==Also known as== | ||
| Line 15: | Line 25: | ||
*'''Brand name:''' Unituxin | *'''Brand name:''' Unituxin | ||
| − | [[Category: | + | ==References== |
| + | |||
| + | [[Category:Drugs]] | ||
[[Category:Intravenous medications]] | [[Category:Intravenous medications]] | ||
| − | |||
[[Category:Anti-GD2 antibodies]] | [[Category:Anti-GD2 antibodies]] | ||
[[Category:Neuroblastoma medications]] | [[Category:Neuroblastoma medications]] | ||
| − | [[Category: | + | [[Category:EMA approved in 2015]] |
| + | [[Category:FDA approved in 2015]] | ||
| + | [[Category:EMA withdrawn in 2017]] | ||
| + | [[Category:Health Canada approved in 2018]] | ||
| + | [[Category:PMDA approved in 2021]] | ||
Latest revision as of 00:58, 29 June 2024
Mechanism of action
From the NCI drug dictionary: A chimeric mouse/human monoclonal antibody with potential antineoplastic activity. Dinutuximab binds to the ganglioside GD2 and induces antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity against GD2-expressing tumor cells.
Route: IV
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.
Diseases for which it is used
History of changes in FDA indication
- 2015-03-10: Initial FDA approval in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. (Based on COG ANBL0032)
History of changes in EMA indication
- 2015-08-14: Initial authorization for the treatment of high risk neuroblastoma.
- 2017-03-20: Authorization withdrawn at the request of the manufacturer, for supply chain reasons
History of changes in Health Canada indication
- 2018-11-29: Initial notice of compliance
History of changes in PMDA indication
- 2021-06-23: Initial approval for the treatment of neuroblastoma following high-dose chemotherapy.
Patient Drug Information
Also known as
- Code names: Ch14.18, MOAB Ch14.18, monoclonal antibody Ch14.18
- Brand name: Unituxin