Discover the elements of efficacy and safety with TREANDA
TREANDA is a uniquely designed single-agent therapy that is indicated for indolent B-cell
NHL that has progressed. In the phase 3 multicenter trial, TREANDA produced a robust 74% overall response
rate (ORR) (95% CI: 64.3, 82.3) in patients previously treated with and resistant to rituximab-containing regimens and
delivered durable response rates that lasted a median of 9.2 months (95% CI: 7.1, 10.8).
TREANDA was also generally well tolerated in 2 clinical studies. Sixty-two percent of patients in the pivotal trial did not receive granulocyte growth factor support. Prophylactic use of growth factors was allowed in conjunction with the study drug; use was discouraged during the first treatment cycle. Investigators were advised to follow the American Society of Clinical Oncology (ASCO) guidelines.1,2
The most common non-hematologic adverse reactions (frequency ≥30%) were nausea (75%), fatigue (57%),
vomiting (40%), diarrhea (37%), and pyrexia (34%) (N=176). The most common hematologic abnormalities (frequency ≥15%)
were lymphopenia (99%), leukopenia (94%), anemia (88%), neutropenia (86%), and thrombocytopenia (86%).
Additionally, TREANDA is a uniquely designed agent that may cause dual cell death via multiple pathways.3-6
The exact mechanism of TREANDA is unknown. Adverse reactions may require interventions such as decreasing
the dose of TREANDA or withholding or delaying treatment.
Please explore the site to learn more about the clinical efficacy of prescribing TREANDA for your
patients with indolent B-cell NHL that has progressed. You’ll also find helpful educational resources
and reimbursement assistance and support that may benefit you and your patients.
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
- Data on file. Cephalon, Inc.
- 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.
- Leoni LM, Bailey B, Reifert J, et al. Bendamustine (Treanda) displays a distinct pattern of cytotoxicity and unique mechanistic features compared with other alkylating agents. Clin Cancer Res. 2008;14:309-317.
- Strumberg D, Harstrick A, Doll K, Hoffmann B, Seeber S. Bendamustine hydrochloride activity against doxorubicin-resistant human breast carcinoma cell lines. Anticancer Drugs. 1996;7:415-421.
- Schwänen C, Hecker T, Hubinger G, et al. In vitro evaluation of bendamustine induced apoptosis in B-chronic lymphocytic leukemia. Leukemia. 2002;16:2096-2105.
- Goodman A. Bendamustine plus rituximab offers new standard of care for treatment of NHL and indolent lymphoma. Oncology NEWS International. 2010;19:1-3. http://www.cancernetwork.com/display/article/10165/1512720. Accessed April 12, 2011.