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Statistically Significant Improvement in Survival Demonstrated in Abraxane Study
The study population included patients who were previously untreated and those who were previously treated (second-line or greater-line therapy) for metastatic breast cancer. In the overall patient population, median survival for those patients receiving ABRAXANE was 10 weeks longer (65.0 weeks v. 55.7 weeks) than for patients receiving Taxol but this difference did not reach statistical significance. However there was a significant prolongation in survival (p=0.016) in patients receiving Abraxane in the second-line or greater setting as compared to those receiving Taxol (56.4 weeks vs. 46.7 weeks). In this group, there was a 29% reduction in the risk of death (i.e., hazard ratio of 0.71) for patients who received Abraxane compared to those who received Taxol.
Abraxane consists only of albumin-bound paclitaxel nanoparticles and no toxic solvents. As previously reported, in the Phase III clinical study, Abraxane demonstrated a superior response rate with an almost doubling of the reconciled target lesion response rate when compared with the solvent-based Taxol®. Because it contains no toxic solvents, this next-generation taxane product enables the administration of 50% more chemotherapy with a well-tolerated safety profile, requires no premedication to prevent hypersensitivity reactions and can be given over 30 minutes using standard IV tubing. The Phase III study was designed to compare ABRAXANETM at a dose of 260 mg/m2 given as a 30-minute infusion without premedication to paclitaxel injection (Taxol®) at 175 mg/m2 given as a 3-hour infusion with standard steroid and antihistamine premedication.
Abraxane was launched on February 7, 2005 by Abraxis Oncology, the proprietary division of APP after having received FDA approval in January. Abraxane is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
Source: American Pharmaceutical Partners, Inc.