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Short-Infusion Bendamustine Wins FDA Nod for Leukemia/Lymphoma Patients

Product expected to be available in early 2016

The FDA has approved Bendeka injection (Teva Pharmaceutical Industries/Eagle Pharmaceuticals), a liquid, low-volume (50 mL), short-time (10-minute) infusion formulation of bendamustine hydrochloride. The drug is approved for the treatment of patients with chronic lymphocytic leukemia (CLL) and for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen. The efficacy of Bendeka in patients with CLL relative to first-line therapies other than chlorambucil has not been established.

Bendeka was granted orphan drug designations for both CLL and indolent B-cell NHL. The treatment is expected to be commercially available to prescribers during the first quarter of 2016.

Bendamustine is a bifunctional mechlorethamine derivative with alkylating properties. Mechlorethamine and its derivatives form electrophilic alkyl groups. These groups in turn form covalent bonds with electron-rich nucleophilic moieties, resulting in inter-strand DNA crosslinks. The bifunctional covalent linkage can lead to cell death via several pathways. The precise mechanism of action of bendamustine remains unknown.

Sources: Teva Pharmaceuticals; November 8, 2015; and Bendeka Prescribing Information; December 2015.

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