FDA Approves New Therapy for Leukemia

The FDA last week approved a new therapeutic option for patients with leukemia.

Bendamustine hydrochloride (Bendeka) injection was approved as a liquid, low-volume (50 mL), and short-time 10-minute infusion formulation of bendamustine.

The drug treats patients with chronic lymphocytic leukemia (CLL) and patients with indolent B-cell non-Hodgkin lymphoma (NHL) that progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen. It has yet to be established if Bendeka’s efficacy in the treatment of CLL is relative to first-line therapies other than chlorambucil.

“We are thrilled that the FDA has approved Bendeka and are excited for what we believe will be a promising launch with Teva,” said Scott Tarriff, president and CEO of Eagle Pharmaceuticals. “Importantly, we believe that patients with CLL or indolent B-cell NHL that has progressed will benefit from the multiple administration options this product offers.”

Bendeka was previously granted Orphan Drug designations for both CLL and indolent B-cell NHL. It is expected to become commercially available during the first quarter of 2016.

“Teva looks forward to commercializing this new bendamustine product, which we believe represents an important benefit to both patients and healthcare providers,” said Paul Rittman, senior vice president and general manager of Teva Oncology. “We are pleased to add Bendeka to Teva’s Oncology portfolio, and bendamustine franchise, furthering our commitment to enhancing treatment options for patients affected by cancer.”