Bendamustine

Note: Previous Treanda formulation discontinued on 2016-03-31 by Teva to switch to Bendeka.

General information

Class/mechanism: Nitrogen mustard, alkylator; bifunctional mechlorethamine derivative containing a purine-like benzimidazole ring which forms electrophilic alkyl groups, resulting in interstrand DNA crosslinks, leading to cell death via several pathways in both quiescent and dividing cells.
Route: IV
Extravasation: irritant (usually), vesicant (rare)

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 established (work in progress)

• Follicular lymphoma
• Mantle cell lymphoma
• Marginal zone lymphoma
• Waldenström macroglobulinemia

Diseases for which it is used

• B-cell lymphoma of mucosa-associated lymphoid tissue
• Chronic lymphocytic leukemia
• Cold agglutinin disease
• Cutaneous T-cell lymphoma
• Diffuse large B-cell lymphoma
• Hairy cell leukemia
• Classical Hodgkin lymphoma
• Light-chain (AL) amyloidosis
• Multiple myeloma
• Peripheral T-cell lymphoma
• Small cell lung cancer
• T-cell prolymphocytic leukemia
• Transformed lymphoma

Patient drug information

• Bendamustine (Treanda) patient drug information (Chemocare)
• Brief patient counseling information can be found in the Bendamustine (Bendeka) package insert
• Brief patient counseling information can be found on page 7 of the package insert
• Bendamustine (Bendeka) patient drug information (UpToDate)

History of changes in FDA indication

As Treanda:

• 2008-03-20: Initial approval for the treatment of patients with chronic lymphocytic leukemia (CLL). (Based on Knauf et al. 2009)
• 2008-10-31: Approved for the treatment of patients with indolent B-cell non-Hodgkin’s lymphoma (NHL) that progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen. (New disease entity; based on SDX-105-01 part 2)

As Bendeka:

• 2015-12-07: Approved for chronic lymphocytic leukemia (CLL). (Based on Knauf et al. 2009)
• 2015-12-07: Approved for indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. (Based on SDX-105-01 part 2)

History of changes in EMA indication

• 2010-07-07: EURD

History of changes in Health Canada indication

• 2012-08-24: Initial notice of compliance

History of changes in PMDA indication

• 2010-10-27: Initial approval for the treatment of relapsed or refractory indolent B-cell non-Hodgkin’s lymphoma and mantle cell lymphoma.
• 2016-08-26: New additional indication and a new dosage for the treatment of chronic lymphocytic leukemia.
• 2016-09-28: New additional indication, dosage, and dosage form for the treatment of chronic lymphocytic leukemia.
• 2016-12-19: revised indication and a new dosage for the treatment of low-grade B-cell non-Hodgkin’s lymphoma and mantle cell lymphoma.
• 2019-03-26: indicated for the treatment prior to tumor-specific T-cell infusion therapy.
• 2021-03-23: New indication and a new dosage for the treatment of relapsed or refractory diffuse large B-cell lymphoma.

Also known as

• Code names: CEP-18083, SDX-105, SyB L-0501
• Generic names: bendamustin hydrochloride, bendamustine hydrochloride, cytostasan hydrochloride
• Brand names: Belrapzo, Bendamax, Bendawel, Bendeka, Bendit, Innomustine, Leuben, Levact, Maxtorin, MyMust, Purplz, Ribomustin, Treakisym, Treanda, Vivimusta, Xyotin