The Phase III clinical trials in the US and China on which this approval was based demonstrated that Abraxane doubled the response rate, significantly prolonged time to tumor progression, and in the US trial, significantly improved overall survival compared to Taxol in the approved indication.
Abraxane is now approved for marketing in 35 countries. Abraxis has three issued Chinese patents covering Abraxane, as well as five additional pending patent applications in China.
Patrick Soon-Shiong, chairman and CEO of Abraxis, said: “The approval for Abraxane in China provides the country with an important new treatment option for women with metastatic breast cancer. With cancer rates on the rise in China, the introduction of a new taxane therapy such as Abraxane is particularly important.”