FDA Approves Treanda® for Initial Treatment of Chronic Lymphocytic Leukemia

Posted on March 8th, 2009 by

FDA Approves Treanda® for Initial Treatment of Chronic Lymphocytic Leukemia

The U.S. Food and Drug Administration has recently approved the drug Treanda® (bendamustine) for the treatment of chronic lymphocytic leukemia (CLL).[1] The approval is based on data indicating that, for patients with CLL, Treanda improved overall response and complete response rates as well as progression-free survival rates compared with the commonly used agent chlorambucil.[2]

Chronic lymphocytic leukemia is the most common form of adult leukemia. The American Cancer Society estimated that approximately 8,000 people would be diagnosed with CLL in 2007. Currently, there are approximately 60,000 people in the United States living with CLL. Chronic lymphocytic leukemia is characterized by the production of atypical lymphocytes. Lymphocytes are specialized immune cells that exist in two forms: B- and T-cells. These cells are produced in the bone marrow and each serves a specific function in helping the body fight infection.

Treanda is a chemotherapy agent that is currently in clinical trials for the treatment of several diseases. One advantage of Treanda is that it does not interfere with another commonly used form of chemotherapy, alkylating agents. Treanda has been marketed and used clinically in Germany for many years in patients with non-Hodgkin’s lymphoma, CLL, multiple myeloma, breast cancer, and other solid tumors such as lung cancer.

The study that led to FDA approval of Treanda was a multicenter trial that included 301 patients with previously untreated CLL. Symptomatic patients requiring treatment received initial therapy with either Treanda or chlorambucil, an alkylating agent that is FDA approved for the treatment of CLL as well as several types of lymphoma.

  • Overall response rates among patients treated with Treanda were 59% compared with 26% among the chlorambucil-treatment group.
  • Additionally, complete response rates were seen in 8% of the patients treated with Treanda compared with less than 1% of those treated with chlorambucil.
  • The average progression-free survival period for the Treanda treatment group was 18 months, 12 months longer than for those treated with chlorambucil.
  • 79% of patients treated with chlorambucil experienced side effects compared with 89% of patients treated with Treanda. Side effects included the need for red blood cell transfusions and were more likely among patients treated with Treanda (20%) compared with those treated with chlorambucil (6%).

Researchers concluded that Treanda should replace chlorambucil for the treatment of CLL, as has been done in some European countries. Future research may investigate the use of Treanda within the United States for treatment of non-Hodgkin’s Lymphoma, multiple myeloma, breast cancer, and other solid tumors such as lung cancer.


[1] Cephalon. Cephalon Receives FDA Approval for TREANDA, a Novel Chemotherapy for Chronic Lymphocytic Leukemia. Available at:http://www.treanda.com/ Accessed March 2008.

[2] Knauf WU, Lissichkov T, Aldaoud A, et al. Bendamustine versus chlorambucil in treatment-naïve patients with B-cell chronic lymphocytic leukemia (B-CLL): Results of an international Phase III study. Blood. 2007;110:609a, abstract 2043.

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