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">[https://www.adcetrispro.com/presinfo/pi.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">[https://seagendocs.com/Adcetris_Full_Ltr_Master.pdf Brentuximab vedotin (Adcetris) package insert]</ref><ref>[[:File:Brentuximabvedotin.pdf | Brentuximab vedotin (Adcetris) package insert (locally hosted backup)]]</ref><ref>[http://www.adcetris.com Adcetris manufacturer's website]</ref>
 
<br>Route: IV
 
<br>Route: IV
 
<br>Extravasation: no information
 
<br>Extravasation: no information
Line 6: Line 6:
 
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://reference.medscape.com/drug/adcetris-brentuximab-vedotin-999680 Medscape],[http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref>
 
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://reference.medscape.com/drug/adcetris-brentuximab-vedotin-999680 Medscape],[http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref>
  
−
==Diseases for which it is used==
+
==Diseases for which it is established ''(work in progress)''==
 
*[[Anaplastic large cell lymphoma]]
 
*[[Anaplastic large cell lymphoma]]
 
*[[Cutaneous T-cell lymphoma]]
 
*[[Cutaneous T-cell lymphoma]]
 +
*[[Classical Hodgkin lymphoma]]
 +
**[[Classical Hodgkin lymphoma, pediatric|Pediatric Hodgkin lymphoma]]
 +
*[[Peripheral T-cell lymphoma]]
 +
 +
==Diseases for which it is used==
 
*[[Diffuse large B-cell lymphoma]]
 
*[[Diffuse large B-cell lymphoma]]
−
*[[Hodgkin lymphoma]]
 
 
*[[Mediastinal gray-zone lymphoma]]
 
*[[Mediastinal gray-zone lymphoma]]
−
*[[Peripheral T-cell lymphoma]]
 
  
 
==Patient drug information==
 
==Patient drug information==
−
*[http://chemocare.com/chemotherapy/drug-info/brentuximab-vedotin.aspx Brentuximab vedotin (Adcetris) patient drug information (Chemocare)]<ref>[http://chemocare.com/chemotherapy/drug-info/brentuximab-vedotin.aspx Brentuximab vedotin (Adcetris) patient drug information (Chemocare)]</ref>
+
*[https://chemocare.com/druginfo/brentuximab-vedotin.aspx Brentuximab vedotin (Adcetris) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/brentuximab-vedotin.aspx Brentuximab vedotin (Adcetris) patient drug information (Chemocare)]</ref>
−
*Brief patient counseling information can be found in the [https://www.adcetrispro.com/presinfo/pi.pdf Brentuximab vedotin (Adcetris) package insert]<ref name="insert"></ref>
+
*Brief patient counseling information can be found in the [https://seagendocs.com/Adcetris_Full_Ltr_Master.pdf Brentuximab vedotin (Adcetris) 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>
  
 
==History of changes in FDA indication==
 
==History of changes in FDA indication==
−
*8/19/2011: Granted [http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm#accelerated accelerated approval] for:
+
===[[Anaplastic large cell lymphoma]]===
−
# 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.
+
*2011-08-19: 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)''
−
# 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.
+
*2018-11-16: 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)''
−
*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)''
+
===[[Classical Hodgkin 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]] mycosis fungoides (MF)]] who have received prior systemic therapy. ''(New disease indication)''
+
*2011-08-19: Granted [http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm#accelerated accelerated approval] for treatment of patients with [[Classical 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)''
−
*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)''
+
**2015-08-17: Converted to full approval for the post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation treatment of patients with [[Classical Hodgkin lymphoma |classical Hodgkin lymphoma (HL)]] at high risk of relapse or progression. ''(new treatment context added; based on AETHERA)''
−
*11/16/2018: Approved in combination with chemotherapy for previously untreated [[Anaplastic large cell lymphoma |systemic anaplastic large cell lymphoma (sALCL)]] or [[Peripheral T-cell lymphoma|other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified]]. ''(New disease and new treatment context)''
+
*2018-03-20: Approved to treat adult patients with previously untreated stage III or IV [[Classical Hodgkin lymphoma |classical Hodgkin lymphoma (cHL)]] in combination with chemotherapy. ''(New treatment context; based on ECHELON-1)''
 +
 
 +
===[[Classical Hodgkin lymphoma, pediatric|Pediatric Hodgkin lymphoma]]===
 +
*2022-11-10: Approved in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide for pediatric patients 2 years of age and older with previously untreated high risk [[Classical Hodgkin lymphoma|classical Hodgkin lymphoma (cHL)]]. ''(Based on COG AHOD1331)''
 +
===[[Cutaneous T-cell lymphoma]]===
 +
*2017-11-09: Regular approval for the treatment of adult patients with [[Cutaneous T-cell lymphoma|primary cutaneous anaplastic large cell lymphoma (pcALCL)]]. ''(New disease indication; based on ALCANZA)''
 +
*2017-11-09: Regular approval for the treatment of adult patients with [[Biomarkers#CD30|CD30]]-[[Biomarkers#Expression|expressing]] [[Cutaneous T-cell lymphoma|mycosis fungoides (MF)]] who have received prior systemic therapy. ''(Based on ALCANZA)''
 +
 
 +
===[[Peripheral T-cell lymphoma]]===
 +
*2018-11-16: 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; based on ECHELON-2)''
 +
==History of changes in EMA indication==
 +
===[[Anaplastic large cell lymphoma]]===
 +
*2012-10-25: Initial authorization as Adcetris. Adcetris is indicated for the treatment of adult patients with relapsed or refractory [[Anaplastic large cell lymphoma |systemic anaplastic large cell lymphoma (sALCL)]]. ''(Based on SG035-0004)''
 +
*2020-05-12: Extension of indication to include in combination with cyclophosphamide, doxorubicin, and prednisone treatment of adults with previously untreated CD30+ [[Anaplastic large cell lymphoma |sALCL]].
 +
===[[Classical Hodgkin lymphoma]]===
 +
*2012-10-25: Initial authorization as Adcetris. Adcetris is indicated for the treatment of adult patients with relapsed or refractory CD30+ [[Classical Hodgkin lymphoma |Hodgkin lymphoma (HL)]] following autologous stem cell transplant (ASCT). ''(Based on SG035-0003)''
 +
*2012-10-25: Initial authorization as Adcetris. Adcetris is indicated for the treatment of adult patients with relapsed or refractory CD30+ [[Classical Hodgkin lymphoma |Hodgkin lymphoma (HL)]] following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option. ''(Based on SG035-0003)''
 +
*2016-06-24: Extension of Indication to include the treatment of adult patients with [[Classical Hodgkin lymphoma |Hodgkin Lymphoma (HL)]] at increased risk of relapse or progression following autologous stem cell transplantation (ASCT).
 +
*2019-02-06: Extension of the existing Hodgkin lymphoma (HL) indication to include the frontline treatment of adult patients with CD30+ Stage IV [[Classical Hodgkin lymphoma |Hodgkin lymphoma (HL)]] in combination with doxorubicin, vinblastine and dacarbazine (AVD). ''(Based on ECHELON-1)''
 +
*Future date (CHMP positive summary): Extension of the existing Hodgkin lymphoma (HL) indication to include the frontline treatment of adult patients with CD30+ Stage III or IV [[Classical Hodgkin lymphoma |Hodgkin lymphoma (HL)]] in combination with doxorubicin, vinblastine and dacarbazine (AVD).
 +
 
 +
===[[Cutaneous T-cell lymphoma]]===
 +
*2017-12-15: Extension of indication for the treatment of adult patients with CD30+ [[Cutaneous T-cell lymphoma|cutaneous T-cell lymphoma (CTCL)]] who require systemic therapy. ''(Based on ALCANZA)''
 +
 
 +
==History of changes in Health Canada indication==
 +
*2013-02-01: Initial notice of compliance with conditions
 +
*2020-05-12: Conditions were met
 +
==History of changes in PMDA indication==
 +
*2014-01-17: Initial approval for the treatment of relapsed or refractory CD30-positive [[Classical Hodgkin lymphoma|Hodgkin's lymphoma]] and [[anaplastic large cell lymphoma]].
 +
*2018-09-21: New indication and a new dosage for the treatment of CD30-positive [[Classical Hodgkin lymphoma|Hodgkin's lymphoma]].
 +
*2019-12-20: New indication and a new dosage for the treatment of CD30-positive [[peripheral T-cell lymphoma]].
 +
*2023-11-24: New indication and a new dosage for the treatment of relapsed or refractory CD30-positive [[cutaneous T-cell lymphoma]].
  
 
==Also known as==
 
==Also known as==
Line 39: Line 73:
 
[[Category:Protein expression-specific medications]]
 
[[Category:Protein expression-specific medications]]
  
−
[[Category:Antibody medications]]
+
[[Category:Anti-CD30 antibody-drug conjugates]]
−
[[Category:Antibody-drug conjugates]]
 
−
[[Category:Anti-CD30 antibodies]]
 
 
[[Category:Microtubule inhibitors]]
 
[[Category:Microtubule inhibitors]]
  
Line 47: Line 79:
 
[[Category:Cutaneous T-cell lymphoma medications]]
 
[[Category:Cutaneous T-cell lymphoma medications]]
 
[[Category:Diffuse large B-cell lymphoma medications]]
 
[[Category:Diffuse large B-cell lymphoma medications]]
−
[[Category:Hodgkin lymphoma medications]]
+
[[Category:Classical Hodgkin lymphoma medications]]
 
[[Category:Mediastinal gray-zone lymphoma medications]]
 
[[Category:Mediastinal gray-zone lymphoma medications]]
 
[[Category:Peripheral T-cell lymphoma medications]]
 
[[Category:Peripheral T-cell lymphoma medications]]
  
 
[[Category:FDA approved in 2011]]
 
[[Category:FDA approved in 2011]]
 +
[[Category:EMA approved in 2012]]
 +
[[Category:Health Canada approved in 2013]]
 +
[[Category:PMDA approved in 2014]]

Revision as of 04:01, 1 June 2024

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 established (work in progress)

Diseases for which it is used

Patient drug information

History of changes in FDA indication

Anaplastic large cell lymphoma

Classical Hodgkin lymphoma

  • 2011-08-19: 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)
    • 2015-08-17: Converted to full approval 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)
  • 2018-03-20: 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)

Pediatric Hodgkin lymphoma

  • 2022-11-10: Approved in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide for pediatric patients 2 years of age and older with previously untreated high risk classical Hodgkin lymphoma (cHL). (Based on COG AHOD1331)

Cutaneous T-cell lymphoma

Peripheral T-cell lymphoma

  • 2018-11-16: 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; based on ECHELON-2)

History of changes in EMA indication

Anaplastic large cell lymphoma

  • 2012-10-25: Initial authorization as Adcetris. Adcetris is indicated for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). (Based on SG035-0004)
  • 2020-05-12: Extension of indication to include in combination with cyclophosphamide, doxorubicin, and prednisone treatment of adults with previously untreated CD30+ sALCL.

Classical Hodgkin lymphoma

  • 2012-10-25: Initial authorization as Adcetris. Adcetris is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT). (Based on SG035-0003)
  • 2012-10-25: Initial authorization as Adcetris. Adcetris is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL) following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option. (Based on SG035-0003)
  • 2016-06-24: Extension of Indication to include the treatment of adult patients with Hodgkin Lymphoma (HL) at increased risk of relapse or progression following autologous stem cell transplantation (ASCT).
  • 2019-02-06: Extension of the existing Hodgkin lymphoma (HL) indication to include the frontline treatment of adult patients with CD30+ Stage IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD). (Based on ECHELON-1)
  • Future date (CHMP positive summary): Extension of the existing Hodgkin lymphoma (HL) indication to include the frontline treatment of adult patients with CD30+ Stage III or IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD).

Cutaneous T-cell lymphoma

  • 2017-12-15: Extension of indication for the treatment of adult patients with CD30+ cutaneous T-cell lymphoma (CTCL) who require systemic therapy. (Based on ALCANZA)

History of changes in Health Canada indication

  • 2013-02-01: Initial notice of compliance with conditions
  • 2020-05-12: Conditions were met

History of changes in PMDA indication

Also known as

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

References

  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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