FDA clears Cephalon's Treanda for CLL

The US Food and Drug Administration has approved Cephalon's Treanda (bendamustine HCl) for injection for chronic lymphocytic leukemia, a slowly-progressing blood and bone marrow disease that strikes 15,000 people in the USA each year. The US drugmaker anticipates that the agent will be available to physicians and patients for CLL in April.

According to the firm, in a randomized, international, multicenter, open-label pivotal study of 301 treatment-naive patients with CLL, those who received Treanda had better clinical outcomes compared to those treated with chlorambucil, an FDA-approved chemotherapy for the condition. Specifically, Treanda patients had a significantly higher overall response (59% versus 26% of patients responded to chlorambucil; p < 0.0001). Those who received Treanda also had a higher complete response rate than chlorambucil patients (8% vs less than 1%), which means that, after treatment, some patients had no signs of disease in their blood. Importantly, Treanda patients also had a significantly longer progression-free survival (18 months vs 6 months; p < 0.0001).

Treanda has a unique chemical structure with two primary components, an alkylating group and a benzimidazole moiety, Cephalon noted, adding that preclinical data suggest it can lead to cell death via several pathways, including by apoptotic and non-apoptotic means.