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ABRAXANE demonstrates longer progression-free survival versus Taxotere in the treatment of first-line metastatic breast cancer

05 Jun 2007 - Abraxis BioScience, Inc. announced the presentation of updated results from an ongoing open-label, randomized head-to-head Phase II clinical trial comparing ABRAXANE(R) for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin bound) and Taxotere(R) (docetaxel) in the first-line treatment of metastatic breast cancer. The updated analysis demonstrated that ABRAXANE administered weekly (150 mg/m2) and every three weeks (300 mg/m2) resulted in longer progression-free survival and an overall improved toxicity profile compared to Taxotere administered every three weeks (100 mg/m2). ABRAXANE administered weekly (100 mg/m2) resulted in comparable progression-free survival and significantly less toxicity compared to the Taxotere arm.
 
Based on these data, Abraxis BioScience plans to initiate a global multi-center head-to-head Phase III registration trial comparing the ABRAXANE at the 150 mg/m2 dose administered weekly to Taxotere at the 100 mg/m2 dose administered every three weeks for the first-line treatment of metastatic breast cancer. The trial is planned to begin in the second half of 2007 and will take place in multiple sites throughout North America, Eastern and Western Europe, and Asia-Pacific.
 
ABRAXANE(TM) for Injectable Suspension (paclitaxel powder for injectable suspension) (nanoparticle, albumin-bound (nab(TM)) paclitaxel) received approval in June 2006 from the Therapeutic Products Directorate of Health Canada under a Notice of Compliance for the treatment of metastatic breast cancer in Canada. The U.S. Food and Drug Administration approved ABRAXANE(TM) in January 2005.