UK life sciences group BTG plc received a boost last week on news that its US licensee Genzyme has been given the go-ahead to market Campath as a first-line treatment for B-cell chronic lymphocytic leukaemia.
“The approval of Campath (alemtuzumab) as a first-line treatment for CLL provides another effective treatment option for newly diagnosed patients and should increase product sales and royalties to BTG,” said Louise Makin, BTG’s chief executive.
Campath was first cleared by the US Food and Drug Administration for third-line use in CLL back in 2001 under accelerated approval conditions, but has now extended its label to first-line use after clinical data demonstrated improved progression-free survival with the drug.
The study, from an international Phase III programme comparing the drug with the conventional therapy chlorambucil in previously untreated patients with B-CLL, met its primary endpoint by demonstrating longer progression-free survival in patients treated with Campath versus chlorambucil, with the former reducing the risk of disease progression or death by 42%.
Patients on Campath also exhibited higher overall and complete response rates that were statistically significant in comparison to patients who were treated with chlorambucil. The Bayer/Genzyme drug also demonstrated a manageable safety profile among study patients.
“Campath is clearly an important single agent for the first-line treatment of CLL,” said Peter Hillmen, of the Leeds General Infirmary in the UK and lead investigator of the aforementioned pivotal study. He added that researchers “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."
The data “add to a growing body of evidence about the effectiveness of Campath across the entire B-CLL treatment pathway," added 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”, he added, claiming that 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”.
The extension of Campath’s label to first-line use is also currently being assessed in Europe.