US biotechnology group Abraxis Bioscience says it plans to launch its taxane therapy Abraxane for breast cancer in Europe in mid-2008, after regulators gave the final seal of approval for the drug.

Specifically, the agent has been cleared for use in patients with metastatic breast cancer who have failed to respond to first-line treatment or are unable to take standard, anthracycline-containing therapies.

Abraxane uses the human protein albumin to deliver the active ingredient paclitaxel and, unlike other chemotherapies, does not contain chemical solvents, eradicating the need for steroids or antihistamines to prevent toxic side effects. Furthermore, the drug is administered in 30 minutes compared to the three hours necessary for solvent-based paclitaxel, the firm noted.

The drug turned in an impressive performance in its Phase III clinical trial programme, doubling the patient response rate and significantly prolonging both progression-free and overall survival compared to Taxol.

‘Therapy of choice’
And it seems this clinical success has already been translated to the marketplace across the Atlantic, where Abraxane is becoming the “taxane therapy of choice for oncologists” given the superior patient outcomes demonstrated in studies, according to principal clinical trial investigator William Gradishar, Professor of Medicine at Northwestern University.

In Europe, there are approximately 300,000 cases of metastatic breast cancer a year, and stressing the advantages this new option offers to patient with the disease, Martine Piccart-Gebhart, Professor in Oncology, Universite Libre de Bruxelles and Head of the Chemotherapy Department at the Jules Bordet Institute, said: “Not only do women with breast cancer benefit from the efficacy of this new drug, it is also more convenient to administer and is well tolerated”.

Abraxis BioScience is currently in the process of setting up its European infrastructure at a cost of around $30 million, and expects to launch Abraxane across Europe in mid-2008. The company also said it expects the drug “to materially contribute to revenues” in 2009.