TREANDA produced meaningful and enduring 2nd-line responses

Single-agent TREANDA produced robust responses in patients previously treated with and resistant to rituximab-containing regimens

TREANDA efficacy
*Independent Review Committee assessment was based on modified International Working Group response criteria (IWG-RC). Modifications to IWG-RC specified that persistently positive bone marrow in patients who met all other criteria for CR would be scored as PR. Bone marrow sample lengths were not required to be ≥20 mm.

  • 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%)

Overall response rate and duration of response were similar in patients 65 years of age and patients <65 years of age

  • No clinically significant differences in the adverse reaction profile between older (≥65 years of age) and younger (<65 years of age) 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

TREANDA produced meaningful responses in disease resistant to prior chemotherapy1

TREANDA response
*Sensitive was defined as a best response of CR or PR to treatment.
Resistant was defined as a best response of no objective response or progressive disease.

  • 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%)

Overall response rate and duration of response were similar in patients 65 years of age and patients <65 years of age

  • No clinically significant differences in the adverse reaction profile between older (≥65 years of age) and younger (<65 years of age) 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

References
  1. 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.
  2. Data on file. Cephalon, Inc.

Single-agent TREANDA provided durable responses that lasted a median of 9 months

Median duration of response

  • 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%)

Overall response rate and duration of response were similar in patients 65 years of age and patients <65 years of age

  • No clinically significant differences in the adverse reaction profile between older (≥65 years of age) and younger (<65 years of age) 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

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 contains information that may differ from the TREANDA Prescribing Information. Please review this article in conjunction with the accompanying full Prescribing Information.

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