Bendamustine is approved as a chemotherapy treatment for non-Hodgkin’s lymphoma (NHL), such as follicular lymphoma (FL), and chronic lymphocytic leukemia (CLL), both alone and in combination with other drugs such as Rituxan (rituximab).
In the U.S., bendamustine was developed as a lymphoma treatment by Cephalon, which now is a subsidiary of Teva Pharmaceuticals. It is marketed under the name Treanda, or the more recent formulation Bendeka.
In Europe, it is marketed under the trade names Levact, Ribomustin, and Ribovact. it also is approved for the treatment of multiple myeloma. In Europe, bendamustine was developed as a lymphoma treatment by Astellas Pharma, before the rights were acquired by Mundipharma.
How bendamustine works
Lymphoma is a type of blood cancer, caused by the abnormal behavior and high production of immune cells called lymphocytes. The two main types of lymphocytes that can become cancerous are called T-cells and B-cells. These cancerous lymphocytes can build up to form tumors in different parts of the body.
Lymphoma can be classed as either Hodgkin’s lymphoma (HL) or NHL, which have multiple subtypes. FL is a common indolent, or slow-growing, B-cell NHL. CLL also is classed as a type of NHL, but the cancerous cells also are found in the bone marrow.
Bendamustine is an alkylating agent, a chemical that can be internalized by cell and cause abnormal bonds between strands of DNA. This is an irreversible process that prevents the cell from multiplying and causes the affected cell to die. Bendamustine works in both cancerous and healthy cells.
Bendamustine in clinical trials
In 2008, the U.S. Food and Drug Administration (FDA) approved Treanda as a first-line treatment for CLL and as a treatment for indolent B-cell NHL, including FL, that had progressed following Rituxan treatment.
In March 2008, bendamustine was approved as a treatment for CLL based on a multicenter, randomized Phase 3 clinical trial comparing bendamustine to the chemotherapy Leukeran (chlorambucil). The results were published in the Journal of Clinical Oncology. A total of 319 previously untreated CLL patients were randomly assigned to either receive bendamustine or Leukeran. The patients who were given bendamustine had a significantly higher response rate at 68 percent, compared to only 31 percent of patients given Leukeran. Furthermore, bendamustine was associated with a significant increase in progression-free survival (21.6 months compared to 8.3 months on Leukeran).
It was approved as a treatment for indolent B-cell NHL in October 2008, based on a single-arm, multicenter, open-label Phase 3 study sponsored by Cephalon (NCT00139841) in 100 patients with indolent NHL. The results, published in the scientific journal Cancer, demonstrated that 75 percent of patients responded to bendamustine treatment, with a median response duration of 9.2 months and a median progression-free survival of 9.3 months.
In December 2015, the FDA approved Teva’s second bendamustine product, Bendeka, for the first line treatment of CLL and the treatment of indolent NHL that had progressed under Rituxan treatment. Bendeka reduces the infusion time of Treanda from 30-60 minutes to 10 minutes.
It is being investigated in combination with several other drugs as a treatment for lymphoma. For example, a Phase 1 trial (NCT01429025) is assessing bendamustine in combination with both Rituxan and Revlimid (lenalidomide) as a treatment for indolent NHL. This trial is ongoing, but no longer recruiting participants.
The most common side effects of bendamustine include nausea, fatigue, vomiting, diarrhea, fever, and reductions in both red and white blood cells. For the full list of side effects see the prescribing information.
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