• Campath
• Clolar
• Fludara
• Leukine
• Mozobil

For more information, please consult the full Prescribing Information (PDF). To see the product site go to www.campath.com

Indication:
Campath is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).

Key Efficacy Results:
In a Phase III trial Campath showed superior first-line efficacy in B-CLL
* Campath was evaluated in a multicenter, randomized, open-label, phase 3 trial versus chlorambucil. A total of 297 patients were randomized to treatment with Campath (n=149) or chlorambucil (n=148); of 149 Campath patients, 124 were responders and 25 were nonresponders.^1,2

24% complete response (CR) achieved with Campath versus 2% with chlorambucil

Median duration of response was longer with Campath (16.2 months; 95% confidence interval (CI), 11.5-23.0 months) versus chlorambucil (12.7 months; 95% CI, 10.2-14.3 months)1

Campath Complete Response was associated with improved progression-free survival (PFS) *1

71% (26 of 36) of Campath Complete Responders remained progression free at 2 years1

Median PFS for Campath Complete Responders had not been reached at 24 months follow-up1

42% reduction in risk of disease progression or death with Campath versus chlorambucil (P=.0001; Hazard Ratio=0.58)

Campath Complete Response was associated with improved time to alternative treatment^*1

77% (28 of 36) of Campath Complete Responders did not require an alternative treatment at 24 months1

59% increase in time to alternative treatment with Campath versus chlorambucil (P=.0001)2

Median time to alternative treatment for Campath Complete Responders had not been reached at 24 months follow-up1

References: 1. Data on file, Genzyme Corporation. 2. Hillmen P, Skotnicki AB, Robak T, et al. Alemtuzumab compared with chlorambucil as first-line therapy for chronic lymphocytic leukemia. J Clin Oncol. 2007;25:5616-5623.

Important Safety Information:

Campath is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).

WARNING: CYTOPENIAS, INFUSION REACTIONS, and INFECTIONS Cytopenias: Serious, including fatal, pancytopenia/marrow hypoplasia, autoimmune idiopathic thrombocytopenia, and autoimmune hemolytic anemia can occur in patients receiving Campath. Single doses of Campath greater than 30 mg or cumulative doses greater than 90 mg per week increase the incidence of pancytopenia. Infusion Reactions: Campath administration can result in serious, including fatal, infusion reactions. Carefully monitor patients during infusions and withhold Campath for Grade 3 or 4 infusion reactions. Gradually escalate Campath to the recommended dose at the initiation of therapy and after interruption of therapy for 7 or more days. Infections: Serious, including fatal, bacterial, viral, fungal, and protozoan infections can occur in patients receiving Campath. Administer prophylaxis against Pneumocystis jiroveci pneumonia (PCP) and herpes virus infections.

In clinical trials, the frequency of infusion reactions was highest in the first week of treatment. The following serious, including fatal, infusion reactions have been identified in post-marketing reports: syncope, pulmonary infiltrates, acute respiratory distress syndrome (ARDS), respiratory arrest, cardiac arrhythmias, myocardial infarction, acute cardiac insufficiency, cardiac arrest, angioedema, and anaphylactoid shock.

Prolonged myelosuppression have been reported in patients receiving Campath. Campath treatment results in severe and prolonged lymphopenia with a concomitant increased incidence of opportunistic infections. Assess CD4+ counts after treatment until recovery to ≥ 200 cells/mL. Obtain complete blood counts (CBC) at weekly intervals during Campath therapy and more frequently if worsening anemia, neutropenia, or thrombocytopenia occurs. Withhold Campath for severe cytopenias (except lymphopenia). Discontinue for autoimmune cytopenias or recurrent/persistent severe cytopenias (except lymphopenia).

Administer only irradiated blood products to avoid transfusion associated Graft versus Host Disease (TAGVHD), unless emergent circumstances dictate immediate transfusion.

Routinely monitor patients for CMV infection during Campath treatment and for at least 2 months following completion of treatment. Withhold Campath for serious infections and during antiviral treatment for CMV infection or confirmed CMV viremia. Initiate therapeutic ganciclovir (or equivalent) for CMV infection or confirmed CMV viremia.

Do not administer live viral vaccines to patients who have recently received Campath.

The most common adverse reactions (≥ 10%) were infusion reactions, cytopenias, cytomegalovirus (CMV) and other infections, nausea, emesis, diarrhea, and insomnia.

For additional safety information and treatment considerations, please see accompanying Full Prescribing Information (PDF).

To see the product site go to www.campath.com.

For information on Healthcare Professional Communications on Investigator Sponsored Trial Data (CALGB10101) that were issued in the European Union in February 2008 and Canada in November 2008, visit http://www.campath.com/hcp/index.jsp.