Difference between revisions of "Brentuximab vedotin (Adcetris)"

Revision as of 12:29, 6 May 2021

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 in the Brentuximab vedotin (Adcetris) package insert^[1]
Brentuximab vedotin (Adcetris) patient drug information (UpToDate)^[5]

History of changes in FDA indication

Anaplastic large cell lymphoma

8/19/2011: Granted accelerated approval for treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen. (Based on SG035-0004)
11/16/2018: Approved in combination with chemotherapy for previously untreated systemic anaplastic large cell lymphoma (sALCL). (New treatment context; based on ECHELON-2)

Cutaneous T-cell lymphoma

11/9/2017: Regular approval for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy. (New disease indication; based on ALCANZA)

Hodgkin lymphoma

8/19/2011: Granted 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. (Based on SG035-0003)
8/17/2015: Approval expanded for the post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation treatment of patients with classical Hodgkin lymphoma (HL) at high risk of relapse or progression. (new treatment context added; based on AETHERA)
3/20/2018: Approved to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy. (New treatment context; based on ECHELON-1)

Peripheral T-cell lymphoma

11/16/2018: Approved in combination with chemotherapy for previously untreated CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified. (New disease indication)

Also known as

Code names: SGN-35, cAC10-vcMMAE
Brand name: Adcetris

References

[insert-1] 1.0 ^1.1 ^1.2 Brentuximab vedotin (Adcetris) package insert

[2] Brentuximab vedotin (Adcetris) package insert (locally hosted backup)

[3] Adcetris manufacturer's website

[4] Brentuximab vedotin (Adcetris) patient drug information (Chemocare)

[5] Brentuximab vedotin (Adcetris) patient drug information (UpToDate)

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[2]

[3]

[4]

[5]

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 ==History of changes in FDA indication==
 ===[[Anaplastic large cell lymphoma]]===
-*8/19/2011:  Granted [http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm#accelerated accelerated approval] for treatment of patients with [[Anaplastic large cell lymphoma | systemic anaplastic large cell lymphoma (sALCL)]] after failure of at least one prior multi-agent chemotherapy regimen.
+*8/19/2011:  Granted [http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm#accelerated accelerated approval] for treatment of patients with [[Anaplastic large cell lymphoma | systemic anaplastic large cell lymphoma (sALCL)]] after failure of at least one prior multi-agent chemotherapy regimen. ''(Based on SG035-0004)''
-*11/16/2018: Approved in combination with chemotherapy for previously untreated [[Anaplastic large cell lymphoma |systemic anaplastic large cell lymphoma (sALCL)]]. ''(New treatment context)''
+*11/16/2018: Approved in combination with chemotherapy for previously untreated [[Anaplastic large cell lymphoma |systemic anaplastic large cell lymphoma (sALCL)]]. ''(New treatment context; based on ECHELON-2)''
 ===[[Cutaneous T-cell lymphoma]]===
-*11/9/2017: [https://www.fda.gov/drugs/informationondrugs/approveddrugs/ucm584543.htm Regular approval] for the treatment of adult patients with [[Cutaneous T-cell lymphoma|primary cutaneous anaplastic large cell lymphoma (pcALCL)]] or [[Biomarkers#CD30|CD30]]-[[Biomarkers#Expression|expressing]] [[Cutaneous T-cell lymphoma|mycosis fungoides (MF)]] who have received prior systemic therapy. ''(New disease indication)''
+*11/9/2017: [https://www.fda.gov/drugs/informationondrugs/approveddrugs/ucm584543.htm Regular approval] for the treatment of adult patients with [[Cutaneous T-cell lymphoma|primary cutaneous anaplastic large cell lymphoma (pcALCL)]] or [[Biomarkers#CD30|CD30]]-[[Biomarkers#Expression|expressing]] [[Cutaneous T-cell lymphoma|mycosis fungoides (MF)]] who have received prior systemic therapy. ''(New disease indication; based on ALCANZA)''
 ===[[Hodgkin lymphoma]]===
-*8/19/2011: Granted [http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm#accelerated accelerated approval] for treatment of patients with [[Hodgkin lymphoma | 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.
+*8/19/2011: Granted [http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm#accelerated accelerated approval] for treatment of patients with [[Hodgkin lymphoma | 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. ''(Based on SG035-0003)''
-*8/17/2015: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm458815.htm Approval expanded] for the post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation treatment of patients with [[Hodgkin lymphoma |classical Hodgkin lymphoma (HL)]] at high risk of relapse or progression. ''(new treatment context added)''
+*8/17/2015: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm458815.htm Approval expanded] for the post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation treatment of patients with [[Hodgkin lymphoma |classical Hodgkin lymphoma (HL)]] at high risk of relapse or progression. ''(new treatment context added; based on AETHERA)''
-*3/20/2018: Approved to treat adult patients with previously untreated stage III or IV [[Hodgkin lymphoma |classical Hodgkin lymphoma (cHL)]] in combination with chemotherapy. ''(New treatment context)''
+*3/20/2018: Approved to treat adult patients with previously untreated stage III or IV [[Hodgkin lymphoma |classical Hodgkin lymphoma (cHL)]] in combination with chemotherapy. ''(New treatment context; based on ECHELON-1)''
 ===[[Peripheral T-cell lymphoma]]===
 *11/16/2018: Approved in combination with chemotherapy for previously untreated [[Biomarkers#CD30|CD30]]-[[Biomarkers#Expression|expressing]] [[Peripheral T-cell lymphoma|peripheral T-cell lymphomas (PTCL)]], including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified. ''(New disease indication)''