Bayer given approval for expanded Campath labeling

Bayer Healthcare announced today that the American Food and Drug Administration (FDA) has given its approval for expanded labelling of Campath which will now include first-line treatment for B-cell chronic lymphocytic leukaemia (B-CLL).

The FDA approved a supplemental Biologics Licence Application (sBLA) for Campath and granted regular approval for single-agent Campath to be used in the treatment of this leading form of adult leukaemia.

Peter Hilmen, of the Leeds General Infirmary, spoke of the importance of Campath as a single agent for first-line treatment of B-CLL.

He declared: “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.”

Bayer had presented data supporting its sBLA at last years Annual Meeting of American Society of Hematology.

As part of its international Phase III clinical trial, the study compared Campath with chlorambucil in previously untreated patients with B-CLL and showed that Campath gave patients longer progression free survival (PFS).

Last month Bayer Healthcare announced that its consumer care segment had signed an agreement to acquire the over-the-counter calcium supplements Citracal from Mission Pharmacal.