Genzyme Corp. and Bayer HealthCare has announced that a supplemental biologics license application (sBLA) for Campath (alemtuzumab) has been submitted to the US Food and Drug Administration (FDA) to expand the current product label to include first-line treatment of B-cell chronic lymphocytic leukaemia (B-CLL).
Campath is currently approved for the treatment of B-CLL patients who have been previously treated with an alkylating agent and have failed fludarabine therapy. Genzyme intends to make a similar filing in Europe within the next couple of weeks to support this label expansion.
Bayer Schering Pharma AG, Germany, markets the product outside the US as MabCampath, and in the US by the company's US affiliate, Bayer HealthCare Pharmaceuticals, as Campath. A label expansion to include first-line therapy would significantly increase the number of potential patients for whom Campath would be indicated.
"Submission of this sBLA is based on positive data from a phase III clinical trial, which showed first-line treatment of B-CLL with Campath resulted in significantly better efficacy with a manageable safety profile as compared to chlorambucil," stated Mark Enyedy, senior vice-president and general manager of Genzyme's oncology business unit. "We are very excited about the potential use of Campath in treating patients earlier in the course of their disease, and about making a very important difference in battling leukaemia."
"In addition to the filing to expand the product's label, we will continue focusing our efforts on further exploring the full potential of Campath in high risk CLL, combination and consolidation therapy, and in seeking approval for treatment via subcutaneous administration," stated Gunnar Riemann, PhD, member of the board management of Bayer Schering Pharma AG, Germany.
The phase III study was an international, randomized, controlled clinical trial conducted to satisfy a post-approval commitment to the FDA to demonstrate clinical benefit of Campath in B-CLL, and to complete the conversion to regular approval. This confirmatory study was completed in accordance with timelines committed to the FDA by Genzyme.