FDA Drug Approval Summary: Alemtuzumab as Single-Agent Treatment for B-Cell Chronic Lymphocytic Leukemia

CME Activity Information
Release Date:	February 27, 2008
Most Recent Review:	February 27, 2008*
Most Recent Update:	February 27, 2008
Date Credit Expires:	February 27, 2010
Time to Complete:	1 hour
Medium:	Internet Online
*Click here to learn more about our review process.

Instructions for Participation

1. Read the following information before beginning the educational activity and click the "Take this course" link at the bottom of the page
2. Study the educational activity
3. Complete the CME quiz and evaluation
4. After successful completion of the CME quiz and evaluation, you will receive the credit or participation certificate

   *The CME quiz and evaluation must be completed by February 27, 2010, in order to receive the credit or participation certificate.

1. Discuss the results of the CAM 307 randomized trial of alemtuzumab in patients with B-cell chronic lymphocytic leukemia.
2. Describe the pretreatment and prophylactic medications recommended for patients treated with alemtuzumab.
3. Identify the most common toxicities seen with alemtuzumab treatment.

All information is submitted and reviewed and found to be scientifically rigorous, based on the best available evidence, fair and balanced, and free of commercial bias. All the recommendations involving clinical medicine in this CME activity are based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients. All scientific research referred to, reported or used in CME in support or justification of a patient care recommendation conforms to the generally accepted standards of experimental design, data collection and analysis.

Any potential conflicts of interests are resolved via The Oncologist's anonymous peer review process All manuscripts are reviewed by the Editorial Board with ad hoc assistance from two or more external experts in the field. All activity planners, authors, and reviewers are required to submit conflict of interest forms. These forms accompany the activity through the peer review process. Any reviewers who have a conflict of interest are recused. When a reviewer is recused, other suitable reviewers with no self-reported conflicts of interests are selected to conduct the reviews. All final publication decisions are made by the Editorial Board. The acceptance of a manuscript is based on its originality and importance to the field as assessed by the Editors.

Credentials: Division of Biologic Oncology Products, Office of Oncology Drug Products, Center for Drug Evaluation and
Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Disclosures: The author has indicated that they discuss the unlabeled, investigational, or alternative use(s) of alemtuzumab, manufactured by Genzyme Corporation, for B-cell chronic lymphocytic leukemia. The author has indicated no relevant commercial relationships.

Jeffrey Summers, M.D.

Credentials: Division of Biologic Oncology Products, Office of Oncology Drug Products, Center for Drug Evaluation and
Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Disclosures: The author has indicated that they discuss the unlabeled, investigational, or alternative use(s) of alemtuzumab, manufactured by Genzyme Corporation, for B-cell chronic lymphocytic leukemia. The author has indicated no relevant commercial relationships.

Patricia Keegan, M.D.

Credentials: Division of Biologic Oncology Products, Office of Oncology Drug Products, Center for Drug Evaluation and
Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Disclosures: The author has indicated that they discuss the unlabeled, investigational, or alternative use(s) of alemtuzumab, manufactured by Genzyme Corporation, for B-cell chronic lymphocytic leukemia. The author has indicated no relevant commercial relationships.

Richard Pazdur, M.D.

Credentials: Division of Biologic Oncology Products, Office of Oncology Drug Products, Center for Drug Evaluation and
Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Disclosures: The author has indicated that they discuss the unlabeled, investigational, or alternative use(s) of alemtuzumab, manufactured by Genzyme Corporation, for B-cell chronic lymphocytic leukemia. The author has indicated no relevant commercial relationships.

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