FDA Approval for Alemtuzumab

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Brand name(s): Campath®

  • Approved for B-cell chronic lymphocytic leukemia

Full prescribing information is available, including clinical trial information, safety, dosing, drug-drug interactions and contraindications.

On September 19, 2007, the U.S. Food and Drug Administration (FDA) expanded the labeling and granted regular approval for single-agent alemtuzumab (Campath®, made by Genzyme Corporation) for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). Alemtuzumab was initially approved in 2001 under accelerated approval regulations and the study described below fulfills the post-marketing commitment to verify its clinical benefit.

In the study, 297 B-CLL patients received either alemtuzumab (after dose escalation, 30 mg intravenously over two hours three times/week on alternate days for 12 weeks) or chlorambucil (40 mg/m2 orally every 28 days for up to 12 cycles.) Patients had Rai stage I - IV CLL, were previously untreated with chemotherapy, and had evidence of progressive disease at entry. Patients receiving alemtuzumab experienced a statistically significant improvement in the primary endpoint of progression-free survival (PFS) compared to those receiving chlorambucil (median PFS: 14.6 vs. 11.7 months; hazard ratio 0.58, p=0.0001 two-sided stratified log-rank test). Patients receiving alemtuzumab also demonstrated an increased overall response rate (83 percent vs. 55 percent; p<0.0001) and an increased complete response rate (24 percent vs. 2 percent; p<0.0001) compared to those receiving chlorambucil. No differences were seen in the FDA-requested interim analysis of survival (24 deaths in each arm.)

The safety profile observed in this trial was consistent with the previously described safety profile provided in the product label.

This summary was provided by Richard Pazdur, M.D., director of the FDA's Division of Oncology Drug Products.

The FDA is the division of the U.S. Department of Health and Human Services charged with ensuring the safety and effectiveness of new drugs and other products. (See "Learn How Drugs and Devices Get Approved.") The FDA's mission is to promote and protect the public health by helping safe and effective products to reach the market in a timely way, and monitoring products for continued safety after they are in use.

  • Updated: July 1, 2013