TREANDA was evaluated in a phase 3 multicenter trial
Phase 3 trial design
*Patients were included if they either achieved no objective response or 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 CR, an unconfirmed complete response (CRu), or PR during the study (ORR=CR+CRu+PR).
TREANDA was studied in a variety of patient types1
TREANDA was evaluated in patients heavily treated with chemotherapy1
Patients in the pivotal trial received a variety of prior treatment regimens1,2*
CHOP=cyclophosphamide, doxorubicin, vincristine, and prednisone;
CVP=cyclophosphamide, vincristine, and prednisone; FC=fludarabine and cyclophosphamide.
*Resistance was defined as a best response of no objective response or progressive disease.
Indications
TREANDA is indicated for the treatment of patients with chronic lymphocytic leukemia
(CLL). Efficacy relative to first-line therapies other than chlorambucil has not
been established.
TREANDA is indicated for the treatment of patients with indolent B-cell non-Hodgkin’s
lymphoma (NHL) that has progressed during or within 6 months of treatment with rituximab
or a rituximab-containing regimen.
Important Safety Information
- Serious adverse reactions, including myelosuppression, infections, infusion reactions
and anaphylaxis, tumor lysis syndrome, skin reactions including SJS/TEN, other malignancies,
and extravasation, have been associated with TREANDA. Some reactions, such as myelosuppression,
infections, and SJS/TEN (when TREANDA was administered concomitantly with allopurinol
and other medications known to cause SJS/TEN), have been fatal. 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
- 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 ≥30%) were nausea, fatigue, vomiting, diarrhea, and pyrexia. The most common hematologic abnormalities associated with TREANDA (frequency ≥15%) were lymphopenia, leukopenia, anemia, neutropenia, and thrombocytopenia
TO REPORT SIDE EFFECTS: Contact us at 1-800-896-5855 or usmedinfo@cephalon.com
- Kahl BS, Bartlett NL, Leonard JP, et al. Bendamustine is effective therapy in patients with rituximab-refractory, indolent B-cell non-Hodgkin lymphoma: results from a multicenter study. Cancer. 2010;116:106-114.
- Data on file. Cephalon, Inc.
