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news.Abraxis BioScience has announced that the European Commission has granted marketing approval for Abraxane powder for suspension for infusion for the treatment of metastatic breast cancer in patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline-containing therapy is not indicated.
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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.
Abraxis BioScience, which is in the process of establishing its European infrastructure, currently expects to launch Abraxane across Europe in mid-2008. The process of receiving country-specific label approvals is underway in several European countries. Abraxane is now approved in 33 countries including the US and Canada. The product is currently under active review in Australia, Russia, Korea and China by their respective regulatory agencies.