Bendamustine in B-Cell Malignancies: The New 46-Year-Old Kid on the Block.

On March 20, 2008, bendamustine HCl (Treanda, Cephalon, Inc.) was approved by the U.S. Food and Drug Administration (FDA) for treatment of chronic lymphocytic leukemia (CLL). This approval was based on a randomized, multicenter trial comparing the test drug (n = 162) to chlorambucil (n = 157) as a first line treatment (1). Overall response rates (ORR) were 68% and 31% for bendamustine and chlorambucil, respectively, and were accompanied with an increased progression-free survival (PFS) with bendamustine. About 6 months later, on October 31, 2008, bendamustine was approved by the FDA for patients with indolent B-cell non-Hodgkin's lymphoma (NHL) that progressed during or within 6 months of treatment with rituximab alone or in combination (n = 100). This approval was based on a single arm clinical trial with an ORR of 74% with 9.2 months of duration of response.