Abraxane gains marketing OK in Australia
Abraxane gains marketing OK in Australia
USA-based Abraxis BioScience and Specialised Therapeutics Australia Pty have announced that approval has been received from the Therapeutic Goods Administration in Australia to market Abraxane (nanoparticle albumin-bound paclitaxel) 100mg 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 the product doubled the response rate and significantly prolonged progression-free survival and overall survival versus Taxol (paclitaxel) in the approved indication. With this action, 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, chief executive of Abraxis BioScience. "In the USA, Abraxane has rapidly grown to become the taxane treatment of choice in its approved indication," he added."
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