The review period in Australia typically is 12 to 18 months from the date that the application is accepted. A marketing authorization application is also currently under review with the European Medicines Agency for use of Abraxane in the treatment of breast cancer.
Abraxane was approved in January 2005 by the FDA and in June 2006 by Health Canada. In addition, Abraxis plans to file for regulatory approval of Abraxane in China, Japan, Korea, and Taiwan, among other countries.
The Australian submission is based on clinical studies, which include a phase III trial of women with breast cancer comparing Abraxane to solvent-based paclitaxel injection Taxol.
In the trial patients who received Abraxane demonstrated a superior investigator overall response rate of 33.2% compared to 18.7% for patients in the paclitaxel injection treatment arm.