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Abraxane approved for first-line breast cancer in Canada

The Canadian healthcare regulator has approved Abraxis BioScience's Abraxane injection for the treatment of metastatic breast cancer.

Abraxane was approved in the US for metastatic breast cancer in January 2005 but only for use after combination chemotherapy treatments had failed. This Canadian approval is the first major market to give the go-ahead for Abraxane to be used as a first-line treatment for the disease.

The company, through its Canadian affiliate of Abraxis Oncology, anticipates launching Abraxane late in the third quarter of 2006.

Data from the pivotal head-to-head trial results demonstrated that Abraxane nearly doubled the overall target lesion response rate versus Taxol and achieved a 37% improvement in progression-free survival when compared to Taxol.

In addition, time to tumor progression versus Taxol was significantly prolonged in patients receiving Abraxane. Abraxane is the first and only protein bound particle chemotherapy, and unlike other taxane-based chemotherapies such as Taxol, does not used solvents to help deliver the medicine to tumors.

“I am very pleased that this approval of Abraxane includes first-line treatment for metastatic breast cancer. This approval allows doctors to offer their patients with metastatic breast cancer Abraxane earlier, providing them a chance to fight tumors more aggressively,” said Dr Patrick Soon-Shiong, CEO and chairman of the board of Abraxis BioScience.