This article is more than 5 years old. Information may no longer be current.
FDA approves Bendeka injection for CLL, non-Hodgkin’s lymphoma
Click Here to Manage Email Alerts
The FDA approved a low-volume bendamustine hydrochloride injection for the treatment of patients with chronic lymphocytic leukemia, as well as for patients with indolent B-cell non-Hodgkin’s lymphoma that has progressed during or within 6 months of treatment with rituximab, according to a press release from the drug’s manufacturer.
Bendamustine hydrochloride injection (Bendeka; Teva Pharmaceuticals, Eagle Pharmaceuticals) — which previously received orphan drug designation — is a liquid, low-volume (50 mL) admixture that has a short-time infusion period of 10 minutes. The previously approved bendamustine formulation (Treanda, Teva Pharmaceuticals) is delivered as a 500 mL admixture over 30 to 60 minutes.
“Importantly, we believe that patients with CLL or indolent B-cell non-Hodgkin’s lymphoma that has progressed will benefit from the multiple administration options this product offers,” Scott Tarriff, president and CEO of Eagle Pharmaceuticals, said in the release.
Adverse events associated with the bendamustine hydrochloride injection included pneumonia, sepsis, hepatitis, and allergic reactions to the injection.
The low-volume bendamustine hydrochloride injection is expected to be available to the public during the first quarter of 2016, according to the release.