FDA approves new treatment for chronic lymphocytic leukemia

May 12, 2008

New treatment for chronic lymphocytic leukemia approved by FDA

Tips to remember: Treanda

Shah reminds pharmacists that CLL is not a curable condition and primarily patients are treated based on worsening symptoms. Although bendamustine has shown a superior response rate and progression-free survival versus chlorambucil, its efficacy versus more efficacious fludarabine-containing regimens, such as FCR (fludarabine, cyclophosphamide, rituximab) and FR (fludarabine and rituximab), remains to be evaluated. "At this point, bendamustine should be an option in the setting where the patient may have been a good candidate for chlorambucil. Many times chlorambucil is considered for elderly patients," Shah explained. And, although manageable, a patient's risk for myelosuppression and emesis should be considered in this treatment decision, he added, since bendamustine did show a higher incidence of the two toxicities during clinical trials.

Bendamustine, which has been granted orphan drug status, should be given as a 100 mg/m2 intravenous infusion over 30 minutes on days one and two of a 28-day cycle, for up to six cycles. Patients should be monitored for myelosuppression during therapy, which may warrant treatment delay or dose reduction. If therapy is discontinued, patients should be monitored closely and treatment restarted based on absolute neutrophil count (ANC) and platelet count recovery. Patients should also be monitored for fever and other signs of infection and treated promptly.

According to Cephalon, a second application for bendamustine was filed with the FDA in December 2007 for treatment of patients with indolent B-cell non-Hodgkin's lymphoma-an indication, if approved, that could greatly expand the market for the drug.