NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Mar 2008
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
12
Data completeness
5/8 — Partial
Priority Review
TREANDA (bendamustine hydrochloride) by Teva is purine-like benzimidazole ring. First approved in 2008.
Drug data last refreshed 11h ago · AI intelligence enriched Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TREANDA (bendamustine HCl) is a small-molecule alkylating agent that forms interstrand DNA crosslinks, inducing cell death in both quiescent and dividing cells. It is approved for hematologic malignancies, primarily chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma (NHL). The exact mechanism remains incompletely understood but involves covalent DNA damage and multiple cell death pathways.
$0.001BPart D
Peak4.6 years to LOEProduct is at peak lifecycle with modest Part D utilization (146 claims in 2023), suggesting stable but limited commercial expansion opportunities for field teams.
Mechanism of Action
purine-like benzimidazole ring. Mechlorethamine and its derivatives form electrophilic alkyl groups. These groups form covalent bonds with electron-rich nucleophilic moieties, resulting in interstrand DNA crosslinks. The bifunctional covalent linkage can lead to cell death via several pathways.…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (12)
Everolimus and Bendamustine Hydrochloride in Treating Patients With Relapsed or Refractory Hematologic Cancer
Started Oct 2014
20 enrolled
Recurrent Adult Diffuse Large Cell LymphomaRecurrent Adult Hodgkin LymphomaRecurrent Grade 1 Follicular Lymphoma+5 more
A Study of Safety and Effectiveness of Bendamustine Hydrochloride in Adult Filipino Patients With Chronic Lymphocytic Leukemia
Started Oct 2014
0Chronic Lymphocytic Leukemia
Bendamustine Hydrochloride, Clofarabine, and Etoposide in Treating Younger Patients With Relapsed or Refractory Hematologic Malignancies
Started Aug 2013
16 enrolled
Hodgkin LymphomaNon-Hodgkin LymphomaAcute Leukemia
A Study to Evaluate the Efficacy and Safety of Bendamustine Hydrochloride Injection
Started May 2012
91 enrolled
Indolent B-Cell Non-Hodgkin's Lymphomas
Rituximab, Bendamustine Hydrochloride, and Lenalidomide in Treating Patients With Refractory or Relapsed Indolent Non-Hodgkin Lymphoma
Started May 2012
26 enrolled
Refractory/Relapsed Indolent Non-Hodgkin Lymphoma
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.