With a unique design that combines two kinds of chemical structures, the anti-tumor activity of TREANDA® can lead to cell death by several pathways. Preclinical studies suggest that TREANDA may cause malignant cell death by damaging the DNA within an indolent B-cell non-Hodgkin’s lymphoma (NHL) cell. The way TREANDA works has been studied in the lab, but how it specifically works is still being investigated.
After treatment with TREANDA, some patients may have no signs of indolent B-cell non-Hodgkin’s lymphoma in their blood. This is called a complete response. Other patients may have a reduced number of indolent B-cell NHL cells or reduced symptoms. This is called a partial response. Some patients may have no response to this treatment. The combined number of patients with complete response and partial response is known as the overall response rate.
TREANDA provided a high overall response rate when used as a single agent in a clinical study. The overall response was 74% for patients whose disease progressed during or within 6 months of treatment with rituximab or a
rituximab-containing regimen.*
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OVERALL RESPONSE TO TREATMENT*
In addition, TREANDA maintained duration of response, which is the amount of time the response to treatment lasts. In this study, the median duration of response was 9.2 months for patients taking TREANDA.
*In a clinical study, TREANDA was examined alone (not combined with additional therapies). In total, 100 patients took TREANDA. The study included patients who were diagnosed with a form of indolent B-cell NHL and who had received prior treatment with rituximab or a rituximab-containing regimen and whose disease progressed during or within 6 months of treatment.
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DELAYED DISEASE PROGRESSION*
*In a clinical study, TREANDA was examined alone (not combined with additional therapies). In total, 100 patients took TREANDA. The study included patients who were diagnosed with a form of indolent B-cell NHL and who had received prior treatment with rituximab or a rituximab-containing regimen and whose disease progressed during or within 6 months of treatment.
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TREANDA for injection is indicated for the treatment of patients with indolent B-cell non-Hodgkin’s lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. TREANDA is also indicated for the treatment of patients with chronic lymphocytic leukemia (CLL). Efficacy relative to first-line therapies other than chlorambucil has not been established.
The following serious adverse reactions have been associated with TREANDA: myelosuppression, infections, infusion reactions and anaphylaxis, tumor lysis syndrome, skin reactions including SJS/TEN, other malignancies, and extravasation. Some of these reactions have been fatal, including myelosuppression, infections, and SJS/TEN (when TREANDA was administered concomitantly with allopurinol and other medications known to cause SJS/TEN). Patients should be monitored closely for these reactions and treated promptly if any occur. Adverse reactions may require interventions such as decreasing the dose of TREANDA, or withholding or delaying treatment. Myelosuppression is frequently severe and should be expected when treating patients with TREANDA.
TREANDA is contraindicated in patients with a known hypersensitivity to bendamustine or mannitol. Women should be advised to avoid becoming pregnant while using TREANDA.
The most common non-hematologic adverse reactions associated with TREANDA (frequency ≥15%) are nausea, fatigue, vomiting, diarrhea, pyrexia, constipation, anorexia, cough, headache, weight decreased, dyspnea, rash, and stomatitis. The most common hematologic abnormalities associated with TREANDA (frequency ≥15%) are lymphopenia, anemia, leukopenia, thrombocytopenia, and neutropenia.
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