NDAINTRAVENOUSSOLUTION
Approved
Dec 2015
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
11
Data completeness
6/8 — Strong
BENDEKA (bendamustine hydrochloride) by Eagle Pharmaceuticals is purine-like benzimidazole ring. First approved in 2015.
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BENDEKA is a bendamustine hydrochloride IV solution approved in 2015 for hematologic malignancies, operating as a bifunctional alkylating agent that forms interstrand DNA crosslinks to induce cell death. It is active against both quiescent and dividing cells through a purine-like benzimidazole mechanism. The exact mechanism of action remains incompletely understood but involves mechlorethamine-derived electrophilic alkyl groups.
$0.003BPart D
Peak6.7 years to LOEPeak-stage product with modest Part D utilization (339 claims, $3M) suggests stable mature franchise with smaller commercial footprint than blockbuster oncology 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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (11)
A Study of Safety and Effectiveness of Bendamustine Hydrochloride in Adult Filipino Patients With Chronic Lymphocytic Leukemia
Started Oct 2014
0Chronic Lymphocytic Leukemia
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
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
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
A Study to Evaluate the Efficacy and Safety of Bendamustine Hydrochloride Injection
Started May 2012
91 enrolled
Indolent B-Cell Non-Hodgkin's Lymphomas
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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.