Abraxis BioScience Announces Approval to Market ABRAXANE for Metastatic Breast Cancer in China
News Jul 15, 2008
Abraxis BioScience, Inc. has announced it 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.
The Phase III clinical trials in the U.S. and China on which this approval was based demonstrated that ABRAXANE doubled the response rate, significantly prolonged time to tumor progression, and in the U.S. trial, significantly improved overall survival versus Taxol® in the approved indication.
Data from the U.S. pivotal head-to-head trial demonstrated that ABRAXANE nearly doubled the overall response rate versus Taxol and achieved a 25% percent improvement in time to tumor 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 and achieved a 26% percent improvement in progression free survival when compared to solvent-based Paclitaxel Injection. 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.
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