Bayer Schering Pharma AG, Germany, and Genzyme Corp., USA, announced that the US 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 for the treatment of B-CLL in patients who have been treated with alkylating agents and who have failed fludarabine therapy. The FDA has determined that the study results submitted in the sBLA fulfil the post-marketing commitment to verify clinical benefit. A label expansion to include first-line treatment is under consideration in Europe.
"Campath is clearly an important single agent for the first-line treatment of CLL. 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," said, Peter Hillmen, MB, ChB, Leeds General Infirmary, Leeds, UK, and the lead investigator of the pivotal study comparing Campath against chlorambucil, the company said in a press statement.
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.
"We are excited that campath can now be used to treat patients in the US earlier in the course of their disease. 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," said Gunnar Riemann, Ph.D., member of the board of management, Bayer Schering Pharma AG".
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 per cent.
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 exhibited a manageable safety profile among study patients, the company said.
"The data that supported this label expansion add to a growing body of evidence about the effectiveness of campath across the entire CLL treatment pathway. 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," said, Mark Enyedy, president, oncology business unit, Genzyme.
According to the Leukaemia and Lymphoma Society, approximately 15,000 new cases of B-cell chronic lymphocytic leukaemia (B-CLL) are diagnosed in the US each year. It is the largest subset of chronic lymphocytic leukaemia (CLL), the most common form of adult leukaemia in the western world. B-CLL is characterized by the accumulation of functionally immature cells in the bone marrow, blood, lymph tissue and other organs. Because these cancerous B cells have a longer than normal life span, they begin to build up and "crowd out" normal, healthy blood cells and can become fatal. Symptoms include fatigue, bone pain, night sweats, fevers, and decreased appetite and weight loss. Bone marrow infiltration leads to a lack of healthy blood cells, thus causing susceptibility to bleedings and weakening of the immune system, exposing the patient to a higher risk of infection.