TREANDA® (bendamustine HCl)

RESPONSE RATES^*

In the pivotal trial

TREANDA^® produced a robust response in patients with indolent B-cell NHL that progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen.

The ORR was significantly >40%, which was the protocol-defined measure of minimal meaningful efficacy (P<.0001)¹
The DR was significantly >4 months, which was the protocol-defined measure of minimal meaningful efficacy (P<.0001)¹

^*Independent Review Committee (IRC) assessment was based on modified International Working Group Response Criteria (IWG-RC). Modifications to IWG RC specified that a persistently positive bone marrow in patients who met all other criteria for CR would be scored as PR. Bone marrow sample lengths were not required to be ≥20 mm

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The efficacy of TREANDA was evaluated in a single-arm pivotal study of 100 patients with indolent B-cell NHL that had progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen. Treatment consisted of 120 mg/m² on Days 1 and 2 of a 21-day treatment cycle, up to 8 cycles. Primary efficacy endpoints were ORR and duration of response (DR). ORR was defined as a best response of a complete response (CR), unconfirmed complete response (CRu), or partial response (PR) during the study (ORR=CR+CRu+PR).

TREANDA provided durable responses that lasted 9 months¹

MEDIAN DURATION OF RESPONSE^*

TREANDA produced meaningful responses in the majority of patients with disease resistant to prior chemotherapy¹

^*Sensitive is defined as a best response of complete response or partial response to treatment.

The majority of patients who were resistant to previous alkylator therapy responded to treatment with TREANDA.

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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References

Data on file. Cephalon, Inc.