Abraxis BioScience, Inc, a fully integrated, global biotechnology company, and Specialised Therapeutics Australia Pty Ltd, announced that approval has been received from the Therapeutic Goods Administration (TGA) in Australia to market Abraxane (nanoparticle albumin-bound paclitaxel) 100 mg powder for injection (suspension) for the treatment of metastatic carcinoma of the breast after failure of anthracycline therapy.
The phase-III clinical trial results on which this approval was based demonstrated that Abraxane doubled the response rate and significantly prolonged progression-free survival and overall survival versus Taxol in the approved indication. With this approval, Abraxane is now cleared for marketing in 36 countries.
"Along with recent approvals in China and South Korea in the Asia-Pacific region, this approval provides an important treatment option for women in Australia with metastatic breast cancer," said Patrick Soon-Shiong, chairman and chief executive officer of Abraxis BioScience. "In the US, Abraxane has rapidly grown to become the taxane treatment of choice in its approved indication. We are pleased to make Abraxane available in the Australian market."
Abraxis will market Abraxane in Australia through a strategic relationship with Specialised Therapeutics Australia, Pty Ltd Based in Melbourne, Specialised Therapeutics Australia plans to launch Abraxane in the fourth quarter of 2008. A reimbursement application to the national Pharmaceutical Benefits Scheme has been submitted.
Abraxane was approved in the European Union in January 2008 for the treatment of metastatic breast cancer after failure of first-line treatment for metastatic disease and in Canada in 2006 for the treatment of metastatic breast cancer including first-line disease.