FDA OKs Teva’s Cancer DrugBy
The US Food and Drug Administration (FDA) has approved Eagle Pharmaceuticals, Inc.’s and Teva Pharmaceutical Industries’ Bendeka (bendamustine hydrochloride) injection, a liquid, low-volume (50 mL) and short-time 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 during or 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 the drug commercially available to prescribers during the first quarter of 2016.
Source: Teva Pharmaceutical Industries