Meaningful results and durable responses were delivered with TREANDA in CLL

Single-agent TREANDA tripled median PFS*

TREANDA vs chlorambucil
*TREANDA (95% CI: 11.7, 23.5) vs chlorambucil (95% CI: 5.6, 8.6).
HR=hazard ratio.

  • The most common non-hematologic adverse reactions (frequency ≥15%) were pyrexia (24%), nausea (20%), and vomiting (16%)
  • The most common hematologic abnormalities (frequency ≥15%) were anemia (89%), thrombocytopenia (77%), neutropenia (75%), lymphopenia (68%), and leukopenia (61%)

TREANDA exceeded median PFS vs chlorambucil in patients <65 years of age and in patients 65 years of age

  • 19 months median PFS with TREANDA vs 8 months median PFS with chlorambucil in patients <65 years of age
  • 12 months median PFS with TREANDA vs 8 months median PFS with chlorambucil in patients ≥65 years of age

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

Single-agent TREANDA more than doubled overall response rates

Overall Response Rates
  • An additional evaluation by an independent committee for response assessment (ICRA) demonstrated a 62% ORR with TREANDA vs 33% with chlorambucil (27% CR vs 2%; 10% nPR vs 3%; 25% PR vs 28% with TREANDA and chlorambucil, respectively) (95% CI: TREANDA 54.40, 69.78; chlorambucil 25.53, 40.69; P<.0001)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 algorithm1

TREANDA delivered meaningful ORR vs chlorambucil in patients <65 years of age and in patients 65 years of age

  • 70% ORR with TREANDA (n=82) vs 30% ORR with chlorambucil (n=69) in patients <65 years of age
  • 47% ORR with TREANDA (n=71) vs 22% ORR with chlorambucil (n=79) in patients ≥65 years of age

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

Reference
  1. Data on file. Cephalon, Inc.

More than 2 times longer median DR with TREANDA vs chlorambucil1*

Median duration of response
*Duration was defined as the time from response to disease progression or death.

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

Reference
  1. Data on file. Cephalon, Inc.

Rapid reduction of absolute lymphocyte counts (ALC) was observed with TREANDA1

ALC during treatment cycle 1
*The median is shown by the square symbol, and the mean is represented by the diamond symbol.

Rapid reduction at Week 1 maintained through Week 41

  • TREANDA resulted in a more profound reduction in ALC: 47% of patients had Grade 3 or 4 lymphopenia compared with only 4% of patients taking chlorambucil
  • This laboratory parameter included both normal lymphocytes and CLL cells, and the higher incidence of Grade 3 or 4 toxicity in the TREANDA treatment group is consistent with the mode of action of TREANDA in this population of 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

Reference
  1. Data on file. Cephalon, Inc.
Cephalon Oncology Financial Assistance
Reimbursement

Contact CORE: Cephalon Oncology Reimbursement Expertise for assistance and support

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This article is based upon the pivotal study that formed the basis for approval of TREANDA. The conclusions reached in this article are consistent with the TREANDA Prescribing Information, however, the article contains information that differs from the TREANDA Prescribing Information. Please review this article in conjunction with the accompanying full Prescribing Information.

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