Alemtuzumab

Also Known As: Alemtuzumab, Lemtrada, Campath, MabCampath, Campath-1H

Alemtuzumab is a drug used in the treatment of chronic lymphocytic leukemia (CLL), cutaneous T-cell lymphoma (CTCL) and T-cell lymphoma under the trade names Campath, MabCampath and Campath-1H, and in the treatment of multiple sclerosis as Lemtrada. It is also used in some conditioning regimens for bone marrow transplantation, kidney transplantation and islet cell transplantation.

It is a monoclonal antibody that binds to CD52, a protein present on the surface of mature lymphocytes, but not on the stem cellsfrom which these lymphocytes are derived. After treatment with alemtuzumab, these CD52-bearing lymphocytes are targeted for destruction.

Alemtuzumab is used as second-line therapy for CLL. It was approved by the US Food and Drug Administration for CLL patients who have been treated with alkylating agents and who have failed fludarabine therapy. It has been approved by Health Canada for the same indication, and additionally for CLL patients who have not had any previous therapies.

(Mab)Campath was withdrawn from the markets in the US and Europe in 2012 to prepare for a higher-priced relaunch of Lemtrada aimed at multiple sclerosis.[1]

A complication of therapy with alemtuzumab is that it significantly increases the risk for opportunistic infections, in particular, reactivation of cytomegalovirus.

Alemtuzumab is indicated for the treatment of B-cell chronic lymphocytic leukemia (B-CLL) in patients who have been treated with alkylating agents and who have failed fludarabine therapy. It is an unconjugated antibody, thought to work via the activation of antibody-dependent cell-mediated cytotoxicity (ADCC).[2]

Multiple sclerosis[edit]

In 2008 early tests at Cambridge University suggest that alemtuzumab might be useful in treating and even reversing the effects of multiple sclerosis.[3] Promising results were reported in 2011 from a phase III trial against Rebif. A combination trial withglatiramer acetate (Copaxone) is being considered, and is expected to work synergistically.[4]

In September 2013 alemtuzumab was approved for first-line use in the EU.

In November 2013, the US FDA issued a comprehensive briefing on alemtuzumab for an agency review meeting. The document highlighted numerous serious safety and efficacy concerns, including substantial doubts about the adequacy of relevant clinical trials.[5] In December 2013, the US FDA indicated that the Lemtrada application is not ready for approval, due to lack of evidence from "adequate and well-controlled studies" that demonstrate that the benefits of the drug outweigh the risks.[6] The CEO of Genzyme, David Meeker, strongly disagreed with this decision and plans to file an appeal.

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