FDA Approval for Alemtuzumab
- 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.