SUPERIOR OVERALL RESPONSE
Compared with chlorambucil...
- 59% ORR for TREANDA® vs 26% with chlorambucil
- An additional evaluation by an independent committee for response assessment (ICRA)
demonstrated a 27% CR with TREANDA vs 2% with chlorambucil (62% ORR vs 33% [95%
CI: TREANDA 54.40, 69.78; chlorambucil 25.53, 40.69; P<.0001]; 10% nPR
vs 3%; 25% PR vs 28% with TREANDA and chlorambucil, respectively).1
- Response results from the ICRA analysis could not be fully verified in some patients.
Therefore, the assignment of CR, nPR, and PR varied between the ICRA analysis and
the results presented in the graph above, which were calculated using a stringent,
prespecified algorithm.1
Study design
The efficacy and safety of TREANDA were assessed compared with chlorambucil in a
randomized, open-label, multicenter, Phase 3 trial in treatment-naïve patients with
confirmed CLL (N=301: TREANDA, n=153; chlorambucil, n=148). Patients were ≤75
years of age with Binet stage B or C CLL; had a WHO Performance Status of 0, 1,
or 2; and had a life expectancy of ≥3 months. Patients were randomized to receive
either single-agent TREANDA 100 mg/m2 intravenous infusion on Days 1
and 2 or single-agent chlorambucil 0.8 mg/kg PO on Days 1 and 15, for up to six
28-day cycles. Primary efficacy endpoints: overall response rate (ORR) and PFS.
ORR was defined as the proportion of patients with a best response of complete response
(CR), nodular partial response (nPR), or partial response (PR). PFS was defined
as the time from randomization to progression of disease or death from any cause,
whichever occurred first.1
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Compared with chlorambucil...
- Median PFS 18 months for TREANDA vs 6 months with chlorambucil*
SUPERIOR PFS: 73% RISK REDUCTION WITH TREANDA†
*TREANDA (95% CI: 11.7, 23.5) vs chlorambucil (95% CI: 5.6, 8.6); CI=confidence
interval
†Reduction in risk of progression of disease or death from any
cause
‡HR=hazard ratio
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Compared with chlorambucil...
- Over 2 times longer median duration of response for TREANDA vs chlorambucil (median
19 months vs 7 months)
MEDIAN DURATION OF RESPONSE IN RESPONDING PATIENTS1
§Duration was defined as the time from response to disease progression
or death
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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Prescribing Information.
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Reference:
- Data on file. Cephalon, Inc.