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 Campath (alemtuzumab) and granted regular approval for single-agent Campath for the treatment of B-cell chronic lymphocytic leukaemia (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 fulfil the post-marketing commitment to verify clinical benefit. A label expansion is under consideration in Europe, a Genzyme press release said.

"Campath is clearly an important single agent for the first-line treatment of CLL," said Peter Hillmen, MB, ChB, of the Leeds General Infirmary, Leeds, United Kingdom, and the lead investigator of the pivotal study comparing Campath against chlorambucil. "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 leukaemia."

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."

Presented at the 48th Annual Meeting of the American Society of Haematology (ASH) conference last year, data supporting the sBLA were part of an international Phase III clinical trial comparing Campath with chlorambucil in previously untreated patients with B-CLL. The study met its primary endpoint by demonstrating longer progression free survival (PFS) in patients treated with Campath versus chlorambucil, with Campath reducing the risk of disease progression or death by 42 percent (p=0.0001).

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

"We are excited that Campath can now be used to treat patients in the U.S. earlier in the course of their disease," said Gunnar Riemann, Ph.D., member of the Board of Management of Bayer Schering Pharma AG. "The ability to now provide Campath as a first-line treatment of the disease will make an important difference in battling B-CLL. It may help patients by offering a potentially more effective treatment approach that can extend progression-free survival."

Campath is marketed in the US by Bayer HealthCare Pharmaceuticals Inc., as Campath, and outside the United States as MabCampath.

Campath is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukaemia (B-CLL). Campath has a boxed warning which includes information on cytopenias, infusion reactions, and infections. The most commonly reported adverse reactions are infusion reactions (fever, chills, hypotension, urticaria, nausea, rash, tachycardia, dyspnoea), cytopenias (neutropenia, lymphopenia, thrombocytopenia, anaemia), and infections (CMV viremia, CMV infection, other infections). In clinical trials, the frequency of infusion reactions was highest in the first week of treatment. Other commonly reported adverse reactions include vomiting, abdominal pain, insomnia and anxiety. The most commonly reported serious adverse reactions are cytopenias, infusion reactions, and immunosuppression/infections.