Difference between revisions of "Brentuximab vedotin (Adcetris)"
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==General information== | ==General information== | ||
Class/mechanism: Anti-CD30 antibody (brentuximab) with protease-cleavable linker to chemotherapeutic agent (monomethyl auristatin E (MMAE, vedotin)). The antibody-drug complex binds to CD30 expressing cells and is internalized, where the active chemotherapeutic agent MMAE is released via proteolytic cleavage of the antibody-drug linker. MMAE is a microtubule disrupting agent that interferes with mitosis, causes cell cycle arrest, and eventual apoptosis.<ref name="insert">[http://www.adcetris.com/_pdf/Final_Adcetris_USPI_Jan12_2012.pdf Brentuximab vedotin (Adcetris) package insert]</ref><ref>[[Media:Brentuximabvedotin.pdf | Brentuximab vedotin (Adcetris) package insert (locally hosted backup)]]</ref><ref>[http://www.adcetris.com Adcetris manufacturer's website]</ref> | Class/mechanism: Anti-CD30 antibody (brentuximab) with protease-cleavable linker to chemotherapeutic agent (monomethyl auristatin E (MMAE, vedotin)). The antibody-drug complex binds to CD30 expressing cells and is internalized, where the active chemotherapeutic agent MMAE is released via proteolytic cleavage of the antibody-drug linker. MMAE is a microtubule disrupting agent that interferes with mitosis, causes cell cycle arrest, and eventual apoptosis.<ref name="insert">[http://www.adcetris.com/_pdf/Final_Adcetris_USPI_Jan12_2012.pdf Brentuximab vedotin (Adcetris) package insert]</ref><ref>[[Media:Brentuximabvedotin.pdf | Brentuximab vedotin (Adcetris) package insert (locally hosted backup)]]</ref><ref>[http://www.adcetris.com Adcetris manufacturer's website]</ref> | ||
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*Brief patient counseling information can be found on [http://www.adcetris.com/_pdf/Final_Adcetris_USPI_Jan12_2012.pdf#page=15 page 15 of the package insert]<ref name="insert"></ref> | *Brief patient counseling information can be found on [http://www.adcetris.com/_pdf/Final_Adcetris_USPI_Jan12_2012.pdf#page=15 page 15 of the package insert]<ref name="insert"></ref> | ||
*[http://www.uptodate.com/contents/brentuximab-vedotin-patient-drug-information Brentuximab vedotin (Adcetris) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/brentuximab-vedotin-patient-drug-information Brentuximab vedotin (Adcetris) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/brentuximab-vedotin-patient-drug-information Brentuximab vedotin (Adcetris) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/brentuximab-vedotin-patient-drug-information Brentuximab vedotin (Adcetris) patient drug information (UpToDate)]</ref> | ||
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+ | ==History of changes in FDA indication== | ||
+ | *8/19/2011: Granted FDA [http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm#accelerated accelerated approval] for: | ||
+ | # Treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates. | ||
+ | # Treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen. | ||
+ | |||
+ | ==Also known as== | ||
+ | SGN-35 and cAC10-vcMMAE. | ||
==References== | ==References== |
Revision as of 20:38, 8 November 2013
General information
Class/mechanism: Anti-CD30 antibody (brentuximab) with protease-cleavable linker to chemotherapeutic agent (monomethyl auristatin E (MMAE, vedotin)). The antibody-drug complex binds to CD30 expressing cells and is internalized, where the active chemotherapeutic agent MMAE is released via proteolytic cleavage of the antibody-drug linker. MMAE is a microtubule disrupting agent that interferes with mitosis, causes cell cycle arrest, and eventual apoptosis.[1][2][3]
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, Medscape,UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is used
Patient drug information
- Brentuximab vedotin (Adcetris) patient drug information (Chemocare)[4]
- Brief patient counseling information can be found on page 15 of the package insert[1]
- Brentuximab vedotin (Adcetris) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 8/19/2011: Granted FDA accelerated approval for:
- Treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates.
- Treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen.
Also known as
SGN-35 and cAC10-vcMMAE.
References
- ↑ 1.0 1.1 1.2 Brentuximab vedotin (Adcetris) package insert
- ↑ Brentuximab vedotin (Adcetris) package insert (locally hosted backup)
- ↑ Adcetris manufacturer's website
- ↑ Brentuximab vedotin (Adcetris) patient drug information (Chemocare)
- ↑ Brentuximab vedotin (Adcetris) patient drug information (UpToDate)