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FDA Approves Expanded Labeling for Alemtuzumab

FDA Approves Expanded Labeling for Alemtuzumab

Genzyme Corp and Bayer HealthCare Pharmaceuticals Inc announced that the US Food and Drug Administration (FDA) has approved a supplemental biologics license application (sBLA) for alemtuzumab (Campath) and granted regular approval for single-agent alemtuzumab for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). Campath was initially approved in 2001 under accelerated approval regulations, and the FDA has determined that the study results submitted in the sBLA fulfill the postmarketing commitment to verify clinical benefit. A label expansion is under consideration in Europe.

Dramatic Change in Treatment

"Campath is clearly an important single agent for the first-line treatment of CLL," said Peter Hillmen, mbchb, of the Leeds General Infirmary, Leeds, UK, and the lead investigator of the pivotal study comparing alemtuzumab against chlorambucil (Leukeran). "We are excited to be entering an era where our improved understanding of CLL, coupled with more advanced laboratory tests and targeted therapy options like Campath, have dramatically changed the first-line treatment approach for this type of leukemia."

Campath works in an entirely different way than chemotherapy, and is the first and only monoclonal antibody approved by the FDA for the treatment of B-CLL. "The data that supported this label expansion add to a growing body of evidence about the effectiveness of Campath across the entire B-CLL treatment pathway," stated Mark Enyedy, president of Genzyme's oncology business unit. "A broader range of patients is now eligible for Campath treatment, regardless of whether they have received prior therapy. The approval also marks an important step in a long-term development plan that is exploring the full potential of Campath in high-risk CLL, combination and consolidation therapy."

Supporting Data

Presented at the 48th annual meeting of the American Society of Hematology conference last year, data supporting the sBLA were part of an international phase III clinical trial comparing alemtuzumab with chlorambucil in previously untreated patients with B-CLL. The study met its primary endpoint by demonstrating longer progression-free survival in patients treated with alemtuzumab vs chlorambucil, with alemtuzumab reducing the risk of disease progression or death by 42% (P = .0001).

Patients receiving alemtuzumab exhibited higher overall and complete response rates that were statistically significant in comparison to patients who were treated with chlorambucil. Alemtuzumab also demonstrated a manageable safety profile among study patients.

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