With a unique design that combines 2 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 a chronic lymphocytic leukemia (CLL) 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 CLL at all in their blood. This is called a complete response. Other patients may have a reduced number of CLL cells or reduced symptoms of CLL. 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 significantly higher overall response rate vs chlorambucil,* another drug approved by the Food and Drug Administration to treat CLL; 59% of patients responded to TREANDA and 26% of patients responded to chlorambucil.
OVERALL RESPONSE TO TREATMENT*
In addition, TREANDA delayed "disease progression," which means that the disease did not get worse for a significant period of time.
Patients receiving TREANDA went an average† of 18 months with no worsening of their CLL versus 6 months with chlorambucil.
*In a clinical study, TREANDA was compared to chlorambucil. Both drugs were given without additional chemotherapeutic agents. There were 153 patients who took TREANDA, and 148 patients who took chlorambucil; patients were 75 years of age or younger and were Binet stage B or C (Rai stages I-IV). None of the patients had ever received treatment for their CLL.
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DELAYED DISEASE PROGRESSION*
*In a clinical study, TREANDA was compared to chlorambucil. Both drugs were given without additional chemotherapeutic agents. There were 153 patients who took TREANDA, and 148 patients who took chlorambucil; patients were 75 years of age or younger and were Binet stage B or C (Rai stages I-IV). None of the patients had ever received treatment for their CLL.
†This number represents the "median" time of delayed disease progression. "Median" is a type of average.
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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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