FDAnews
www.fdanews.com/articles/62568-abraxane-approved-in-canada-for-metastatic-breast-cancer

ABRAXANE APPROVED IN CANADA FOR METASTATIC BREAST CANCER

September 15, 2006

Abraxis announced that it has received Health Canada approval for Abraxane for the treatment of metastatic breast cancer, including previously untreated metastatic disease. Abraxane, new to the class of taxane cancer therapies, is now commercially available, after having been available to Canadian since April through a compassionate use program.

Abraxane uses the natural properties of a human protein, albumin, to deliver the drug more effectively to tumors. By wrapping the albumin around the active drug, Abraxane can be administered to patients at higher doses without the use of toxic solvents, which are often the cause of significant treatment-related side effects of other taxane chemotherapies.

Data from head-to-head trials demonstrates that patients treated with Abraxane experienced nearly double the overall response rate when compared with Taxol and achieved a 37 percent improvement in progression-free survival. Time to tumor progression and overall survival was also significantly prolonged in patients receiving Abraxane.

Patients do not need to be premedicated before treatment with Abraxane to avoid allergic reactions that are sometimes caused by the solvents in other taxane chemotherapies. With a lower risk of allergic reaction, patients can receive treatment in as little at 30 minutes compared with over three hours needed for solvent-based taxanes.