LOS ANGELES -- July 14, 2008 -- The China State Food and Drug Administration has approved albumin-bound paclitaxel ABI-007 (Abraxane) for the treatment of breast cancer after failure of standard chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. The phase 3 clinical trials in the United States and China, on which this approval was based, demonstrated that albumin-bound paclitaxel doubled the response rate, significantly prolonged time to tumour progression, and in the US trial, significantly improved overall survival versus paclitaxel (Taxol) in the approved indication. Abraxane is a solvent-free nanoparticle including albumin that encapsulates paclitaxel. Taxol consists of the taxane in a cremophor solvent.
Data from the pivotal US head-to-head trial demonstrated that albumin-bound paclitaxel nearly doubled the overall response rate versus paclitaxel and achieved a 25% improvement in time to tumour progression when compared with paclitaxel. Furthermore, patients receiving albumin-bound paclitaxel in the second-line setting had a significantly prolonged survival by an additional 27% compared with solvent-based paclitaxel. The tolerability with albumin-bound paclitaxel and paclitaxel was comparable, despite the 50% greater dose of paclitaxel administered as albumin-bound paclitaxel.
A second head-to-head trial in Chinese patients with metastatic breast cancer further demonstrated the improved efficacy of albumin-bound paclitaxel compared with solvent-based paclitaxel injection. Albumin-bound paclitaxel significantly improved overall response rate versus solvent-based paclitaxel injection and achieved a 26% improvement in progression-free survival when compared to solvent-based paclitaxel injection. Both therapies had similar toxicity profiles.
Albumin-bound paclitaxel is now approved for marketing in 35 countries.
SOURCE: Abraxis Bioscience, Inc.
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