NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Mar 2008
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
12
Data completeness
6/8 — Strong
Priority Review
TREANDA (bendamustine hydrochloride) by Teva is purine-like benzimidazole ring. Approved for non-hodgkin lymphoma, chronic lymphocytic leukemia, small lymphocytic lymphoma. First approved in 2008.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TREANDA (bendamustine hydrochloride) is an IV chemotherapy agent with a unique purine-like benzimidazole structure that forms DNA interstrand crosslinks, inducing cell death in both quiescent and dividing cells. It is approved for 11 hematologic malignancies including non-Hodgkin lymphoma, chronic lymphocytic leukemia, and multiple myeloma. The exact mechanism of action remains incompletely understood despite over 15 years of clinical use.
$1MPart D
PeakStable
5.0 years to LOEPeak-stage product with minimal Part D penetration signals a mature, low-growth commercial profile with likely smaller brand team relative to blockbuster competitors.
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 (3)
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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.