FDA approves Bendeka (bendamustine hydrochloride), a 10 minute infusion to treat CLL- Teva

Teva Pharmaceutical Industries and Eagle Pharmaceuticals announced that the FDA has approved Bendeka (bendamustine hydrochloride) injection, formerly EP 3102, a liquid, low-volume (50 mL) and 10-minute infusion formulation of bendamustine. Bendeka 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 within six months of treatment with rituximab or a rituximab-containing regimen. Efficacy in 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. Under the February 2015 exclusive license agreement for Bendeka, Teva is responsible for all US commercial activities for the product including promotion and distribution. Teva expects to make Bendeka commercially available to US prescribers during the first quarter of 2016.