Abraxis BioScience, Inc., a fully integrated biotechnology company, has received approval from the China State Food and Drug Administration to market Abraxane Paclitaxel for injection (Albumin Bound) for the treatment of breast cancer after failure of standard chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.

Abraxane is a solvent-free chemotherapy treatment option for metastatic breast cancer.
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 tumour progression, and in the US trial, significantly improved overall survival versus Taxol in the approved indication.

Data from the US pivotal head-to-head trial demonstrated that Abraxane nearly doubled the overall response rate versus Taxol (33% vs. 19%; P = .001) and achieved a 25% percent improvement in time to tumour progression when compared to Taxol. Furthermore, patients receiving Abraxane in the second-line setting had a significantly prolonged survival by an additional 27% compared to solvent-based Taxol. The tolerability with Abraxane and Taxol was comparable, despite the 50% greater dose of paclitaxel administered as Abraxane.

A second head-to-head trial in Chinese patients with metastatic breast cancer further demonstrated the improved efficacy of Abraxane compared to solvent-based Paclitaxel Injection. Abraxane significantly improved overall response rate versus solvent-based Paclitaxel Injection (54% vs. 29%; P = less than .001) and achieved a 26% percent improvement in progression free survival when compared to solvent-based Paclitaxel Injection (7.6 months vs. 6.2 months; P = 0.118). Both therapies had similar toxicity profiles.

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. In the Asia-Pacific region, Abraxane was approved in India in November 2007 and in Korea in April 2008.

Abraxane is under regulatory review by the Therapeutic Goods Administration (TGA) in Australia and by the Federal Authority for Healthcare and Social Development Regulation in Russia for the treatment of breast cancer. In March 2008, the Japanese licensee of Abraxis, Taiho Pharmaceutical Co., filed a New Drug Application (J-NDA) with the Ministry of Health, Labour and Welfare to market Abraxane for the treatment of breast cancer in Japan. Abraxane was developed by Abraxis BioScience and is marketed in the United States under a co-promotion agreement between Abraxis and AstraZeneca