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.
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.
For more information call (800) 896-5866 or visit Bendeka.com.