TREANDA® (bendamustine HCl)

TREANDA^® is indicated for the treatment of patients with indolent B-cell NHL that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen.*

STUDY DESIGN

*Patients were included if they relapsed within 6 months of either the first dose (monotherapy) or last dose (maintenance regimen or combination therapy) of rituximab.

^†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).

BASELINE CHARACTERISTICS

The efficacy and safety of TREANDA were evaluated in previously treated patients²

PRIOR TREATMENT HISTORY

PERCENTAGE OF PATIENTS RESISTANT TO PREVIOUS REGIMENS^‡

^‡Resistant is defined as a best response of no objective response or progressive disease.

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.

Please see full Prescribing Information.

References:

Kahl BS, Bartlett NL, Leonard JP, et al. Bendamustine is effective therapy in patients with rituximab-refractory indolent B-cell non-Hodgkin’s lymphoma: results from a multicenter study. Submitted for publication.
Data on file. Cephalon, Inc.