The submission in Japan includes four clinical studies that were part of the original new drug application in the US, including the randomized, pivotal Phase III multicenter, comparative study of 460 women with metastatic breast cancer conducted by Abraxis and published in the Journal of Clinical Oncology. Additionally, the submission in Japan included several subsequent Phase I and Phase II studies, including two conducted by Taiho.
Abraxane is now approved in Europe, the US, India and Canada, encompassing a total of 33 countries. Abraxane also is under active review in Australia, Russia, Korea and China by their respective regulatory agencies. Abraxane is said to be the first and only approved protein-bound nanometer-sized solvent-free taxane and is the first commercial product to validate Abraxis’s proprietary nab technology platform.
Patrick Soon-Shiong, chairman and CEO of Abraxis BioScience, said: “This submission in Japan was the result of close collaboration between the Taiho and Abraxis development teams, and followed the completion of Phase I bridging studies in Japan.”