Brentuximab vedotin (Adcetris)

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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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