Treanda® Approved for Recurrent NHL

Treanda® Approved for Recurrent NHL

The United States Food and Drug Administration has approved Treanda® (bendamustine hydrochloride) for the treatment of slow-growing (indolent) B-cell non-Hodgkin’s lymphoma (NHL) that has progressed either during therapy or within six months of therapy including Rituxan® (rituximab). Treanda is already approved for the treatment of chronic lymphocytic leukemia (CLL).

Non-Hodgkin®s lymphoma is a form of cancer that begins in the cells of the lymph system. The lymph system includes the spleen, thymus, tonsils, bone marrow, lymph nodes, and circulating immune cells. The main cells in the lymph system are lymphocytes, which exist in two forms: B and T-cells. Each of these cells has a specific function in fighting infection.

NHL is characterized by the excessive accumulation of atypical (cancerous) lymphocytes. These lymphocytes can crowd the lymph system and suppress the formation and function of other immune and blood cells. NHL is categorized by the type of lymphocyte it involves and by the rate at which the cancer grows; both are determined by the cells® appearance under a microscope.

Rituxan is targeted specifically against B-cells. Rituxan is commonly used for the treatment of indolent B-cell NHL; however, some patients with this disease may quickly progress or not respond to Rituxan. Researchers continue to evaluate novel agents that may improve outcomes in the treatment of NHL that has recurred or not responded to Rituxan.

Treanda is a chemotherapy agent that combines the action of two types of agents, which attack cancerous cells through distinct pathways. In addition to being approved for CLL and now NHL, Treanda is also being evaluated in clinical trials including several other types of cancers.

The trial prompting the new indication for Treanda included 100 patients with indolent B-cell NHL whose cancer had progressed within six months of therapy with Rituxan. Patients were treated with Treanda as a single agent.

  • The overall anticancer response rate to Treanda was 74%.
  • Responses lasted for a median of 9 months.
  • Patients were alive without cancer progression for a median of 9 months.
  • Treanda was well tolerated.

Patients with B-cell NHL that has progressed within six months of therapy with Rituxan may wish to speak with their physician regarding their individual risks and benefits of treatment with Treanda.

Reference: Cephalon. Cephalon Receives FDA Approval for TREANDA to Treat Patients with Relapsed Indolent Non-Hodgkin’s Lymphoma. Available at: http://www.cephalon.com/media/news-releases/article/cephalon-receives-fda-approval-for-treanda-to-treat-patients-with-relapsed-indolent-non-hodgkins-ly/. Accessed October 31, 2008.

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