Brentuximab vedotin (Adcetris)

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.
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.

Diseases for which it is used

• Anaplastic large cell lymphoma
• Cutaneous T-cell lymphoma
• Diffuse large B-cell lymphoma
• Hodgkin lymphoma
• Mediastinal gray-zone lymphoma
• Peripheral T-cell lymphoma

Patient drug information

• Brentuximab vedotin (Adcetris) patient drug information (Chemocare)
• Brief patient counseling information can be found in the Brentuximab vedotin (Adcetris) package insert
• Brentuximab vedotin (Adcetris) patient drug information (UpToDate)

History of changes in FDA indication

• 8/19/2011: Granted FDA accelerated approval for:

1. 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.
2. Treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen.

• 8/17/2015: FDA 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."
• 11/9/2017: FDA 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."
• 3/20/2018: FDA approved "to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy."

Also known as

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