Difference between revisions of "Daratumumab (Darzalex)"
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m (PeterYang moved page Daratumumab (HuMax-CD38) to Daratumumab (Darzalex): FDA approval) |
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| − | = | + | ==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.accessdata.fda.gov/drugsatfda_docs/label/2015/761036s000lbl.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> | |
| + | <br>Route: IV | ||
| + | <br>Extravasation: no information | ||
| − | =Preliminary data= | + | 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> |
| − | ==[[Multiple myeloma]]== | + | |
| + | ==Diseases for which it is used== | ||
| + | *[[Multiple myeloma]] | ||
| + | |||
| + | ==Patient drug information== | ||
| + | *[http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/761036s000lbl.pdf Daratumumab (Darzalex) package insert]<ref name="insert"></ref> | ||
| + | |||
| + | ==Preliminary data== | ||
| + | ===[[Multiple myeloma]]=== | ||
<!-- # '''Abstract:''' Plesner, Torben, Lokhorst, Henk, Gimsing, Peter, Nahi, Hareth, Lisby, Steen, Richardson, Paul G. Daratumumab, a CD38 Monoclonal Antibody in Patients with Multiple Myeloma - Data From a Dose-Escalation Phase I/II Study. ASH Annual Meeting Abstracts 2012 120: 73 [http://abstracts.hematologylibrary.org/cgi/content/abstract/120/21/73 link to abstract] --> | <!-- # '''Abstract:''' Plesner, Torben, Lokhorst, Henk, Gimsing, Peter, Nahi, Hareth, Lisby, Steen, Richardson, Paul G. Daratumumab, a CD38 Monoclonal Antibody in Patients with Multiple Myeloma - Data From a Dose-Escalation Phase I/II Study. ASH Annual Meeting Abstracts 2012 120: 73 [http://abstracts.hematologylibrary.org/cgi/content/abstract/120/21/73 link to abstract] --> | ||
# Lokhorst HM, Plesner T, Laubach JP, Nahi H, Gimsing P, Hansson M, Minnema MC, Lassen U, Krejcik J, Palumbo A, van de Donk NW, Ahmadi T, Khan I, Uhlar CM, Wang J, Sasser AK, Losic N, Lisby S, Basse L, Brun N, Richardson PG. Targeting CD38 with Daratumumab Monotherapy in Multiple Myeloma. N Engl J Med. 2015 Sep 24;373(13):1207-19. Epub 2015 Aug 26. [http://www.nejm.org/doi/full/10.1056/NEJMoa1506348 link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/26308596 PubMed] | # Lokhorst HM, Plesner T, Laubach JP, Nahi H, Gimsing P, Hansson M, Minnema MC, Lassen U, Krejcik J, Palumbo A, van de Donk NW, Ahmadi T, Khan I, Uhlar CM, Wang J, Sasser AK, Losic N, Lisby S, Basse L, Brun N, Richardson PG. Targeting CD38 with Daratumumab Monotherapy in Multiple Myeloma. N Engl J Med. 2015 Sep 24;373(13):1207-19. Epub 2015 Aug 26. [http://www.nejm.org/doi/full/10.1056/NEJMoa1506348 link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/26308596 PubMed] | ||
| − | =Also known as= | + | ==History of changes in FDA indication== |
| − | JNJ-54767414 | + | *11/16/2015: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm472904.htm FDA approved] "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."<ref name="insert"></ref> |
| + | |||
| + | ==Also known as== | ||
| + | HuMax-CD38, JNJ-54767414 | ||
| + | |||
| + | ==References== | ||
| + | <references/> | ||
[[Category:Drug index]] | [[Category:Drug index]] | ||
| Line 14: | Line 30: | ||
[[Category:Intravenous chemotherapy]] | [[Category:Intravenous chemotherapy]] | ||
| − | |||
[[Category:Anti-CD38 antibodies]] | [[Category:Anti-CD38 antibodies]] | ||
| − | + | [[Category:Malignant hematology medications]] | |
[[Category:Multiple myeloma medications]] | [[Category:Multiple myeloma medications]] | ||
| − | [[Category: | + | [[Category:Drugs FDA approved in 2015]] |
Revision as of 20:32, 16 November 2015
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
Preliminary data
Multiple myeloma
- Lokhorst HM, Plesner T, Laubach JP, Nahi H, Gimsing P, Hansson M, Minnema MC, Lassen U, Krejcik J, Palumbo A, van de Donk NW, Ahmadi T, Khan I, Uhlar CM, Wang J, Sasser AK, Losic N, Lisby S, Basse L, Brun N, Richardson PG. Targeting CD38 with Daratumumab Monotherapy in Multiple Myeloma. N Engl J Med. 2015 Sep 24;373(13):1207-19. Epub 2015 Aug 26. link to original article PubMed
History of changes in FDA indication
- 11/16/2015: FDA approved "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."[1]
Also known as
HuMax-CD38, JNJ-54767414