Discover the elements of efficacy and safety with TREANDA
TREANDA is a uniquely designed single-agent therapy that is indicated for chronic lymphocytic leukemia (CLL). In the pivotal
phase 3 trial, TREANDA demonstrated improved efficacy vs chlorambucil, tripling
median progression-free survival (PFS) (18 months [95% CI: 11.7, 23.5] vs 6 months [95% CI: 5.6, 8.6])
and doubling the overall response rates (ORR) (59% [95% CI: 51.03, 66.62] vs 26% [95% CI: 18.64, 32.71]).1
TREANDA was also generally well tolerated in the clinical trial. Patients were adherent
to the dosing schedule and most patients did not receive granulocyte growth factor
support (use of growth factors was discouraged according to protocol) or experience
alopecia.1,2
The most common non-hematologic adverse reactions (frequency ≥15%) were pyrexia
(24%), nausea (20%), and vomiting (16%) (n=153). The most common hematologic abnormalities
(frequency ≥15%) were anemia (89%), thrombocytopenia (77%), neutropenia (75%), lymphopenia
(68%), and leukopenia (61%) (n=150).
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 CLL. 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 ≥15%) were pyrexia, nausea, and vomiting. The most common hematologic abnormalities associated with TREANDA (frequency ≥15%) were anemia, thrombocytopenia, neutropenia, lymphopenia, and leukopenia
TO REPORT SIDE EFFECTS: Contact us at 1-800-896-5855 or usmedinfo@cephalon.com
- Data on file. Cephalon, Inc.
- Knauf WU, Lissichkov T, Aldaoud A, et al. Phase III randomized study of bendamustine
compared with chlorambucil in previously untreated patients with chronic lymphocytic
leukemia. J Clin Oncol. 2009;27:4378-4384.
- 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.