The Food and Drug Administration (FDA) has approved Bendeka (bendamustine HCl) injection for the treatment of patients with chronic lymphocytic leukemia (CLL) and for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL). The announcement was made today by Teva Pharmaceutical Industries Ltd. and Eagle Pharmaceuticals, Inc. Concerning indolent B-cell non-Hodgkin lymphoma, the treatment is indicated for patients who have progressed during six months of treatment with rituximab or a rituximab–containing regimen.

Bendeka is a low-volume and short-time infusion (10 minutes) formulation of bendamustine, which is a bifunctional mechlorethamine derivative containing a purine-like benzimidazole ring that form 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. It is active against both quiescent and dividing cells.

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The FDA granted Bendeka Orphan Drug Designations for both the CLL and indolent B-cell NHL indications. 

Bendeka is available as a 100mg/4mL strength solution in 5mL multi-dose vials. It is expected to launch during the first quarter of 2016.

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