Newly-approved injection for treatment of CLL
Drug has long history, studies
Bendamustine hydrochloride for injection (Treanda®) was approved on March 20, 2008, for the treatment of patients with chronic lymphocytic leukemia (CLL).
The bifunctional mechlorethamine derivative was widely studied over two decades in East Germany, where it was a popular chemotherapeutic agent for cancer, including non-Hodgkin's lymphoma.1
In a study comparing bendamustine with chlorambucil in treating 301 treatment-naÏve patients with Binet Stage B or C CLL, bendamustine demonstrated superior efficacy, according to the FDA.
Hospital pharmacists considering the impact of stocking bendamustine might consider the other literature regarding its use for treating other diseases, as well. Here are some examples:
• Soft-tissue sarcomas (STS): Bendamustine has shown activity in the treatment STS, which typically strikes young patients, who often have early metastasis and limited response to chemotherapy.2
• Catastrophic antiphospholipid antibody syndrome (CAPS): In one case study, a 69-year-old woman with splenic marginal-zone lymphoma was diagnosed with CAPS. Her treatment included six cycles of bendamustine monotherapy (90 mg/m2) and heparin. This led to a partial remission of lymphoma and lupus anticoagulant negativity.3
Bendamustine has been found to cause neutropenia in 28% of patients studied; thrombocytopenia in 23%; anemia in 19%; and leukopenia in 18%, according to the FDA. Other frequent adverse reactions are pyrexia (24%), nausea (20%), and vomiting (16%).
Four patients in a randomized CLL clinical study experienced worsening hypertension, and three of these were a hypertensive crisis, managed with oral medications and resolved.
A complete listing of adverse reactions can be found at: www.fda.gov/cder/foi/label/2008/022249lbl.pdf.
References
- Forero-Torres A, Saleh MN. Bendamustine in non-Hodgkin lymphoma: The double-agent that came from the Cold War. Clin Lymphoma Myeloma 2007;8(Suppl 1):S13-S17.
- Kopp HG, Patel S, Brucher B, et al. Potential combination chemotherapy approaches for advanced adult-type soft-tissue sarcoma. Am J Clin Dermatol 2008;9:207-217.
- Manner H, Jung B, Tonassi L, et al. Successful treatment of catastrophic antiphospholipid antibody syndrome (CAPS) associated with splenic marginal-zone lymphoma with low-molecular weight heparin, rituximab and bendamustine. Am J Med Sci 2008;335:394-397.
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