Ibritumomab tiuxetan (Zevalin)

General information

Class/mechanism: Anti-CD20 antibody chelated by tiuxetan to a radioactive agent (Y-90, yttrium-90; or In-111, indium-111). Y-90 emits beta radiation, which causes cellular damage via free radicals. This results in damage to cells which express the CD20 antigen (human B-lymphocyte-restricted differentiation antigen, Bp35).
Route: IV
Extravasation: potential vesicant

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, UpToDate (courtesy of Lexicomp), or the prescribing information.

Diseases for which it is established (work in progress)

• Follicular lymphoma

Diseases for which it is used

• Diffuse large B-cell lymphoma
• Mantle cell lymphoma
• Marginal zone lymphoma

Patient drug information

• Ibritumomab tiuxetan (Zevalin) package insert
• Ibritumomab tiuxetan (Zevalin) patient drug information (Chemocare)
• Ibritumomab tiuxetan (Zevalin) patient drug information (UpToDate)

History of changes in FDA indication

• 2002-02-19: Granted FDA accelerated approval for the treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma, including patients with Rituximab (Rituxan) refractory follicular non-Hodgkin’s lymphoma. (Based on Wiseman et al. 2002, Witzig et al. 2002a, Witzig et al. 2002b)
  • 2009-09-03: Granted FDA full approval; label expanded for the treatment of previously untreated follicular NHL in patients who achieve a partial or complete response to first-line chemotherapy. (Based on FIT)

History of changes in EMA indication

• 2004-01-16: Initial authorization
• Uncertain date: [90Y]-radiolabelled Zevalin is indicated in adults as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma. The benefit of Zevalin following rituximab in combination with chemotherapy has not been established.
• Uncertain date: [90Y]-radiolabelled Zevalin is indicated for the treatment of adult patients with rituximab relapsed or refractory CD20+ follicular B-cell non-Hodgkin's lymphoma (NHL).

History of changes in PMDA indication

• 2008-01-25: Initial approval for the treatment of relapsed or refractory, CD20-positive lymphomas of the following: low-grade B-cell non-Hodgkin’s lymphoma and mantle cell lymphoma.

Also known as

• Brand name: Zevalin