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FDA Approves Abraxane for Metastatic Breast Cancer
The approval marks a new class of "protein-bound particle" drugs, now made possible by ABI's proprietary nanoparticle albumin-bound (nab(TM)) technology. ABRAXANE is the first in this new class of drugs.
ABRAXANE, consisting only of albumin-bound paclitaxel nanoparticles, is free of toxic solvents and demonstrated a superior response rate with an almost doubling of the reconciled target lesion response rate when compared with the solvent-based Taxol® in a prospectively randomized trial of 460 patients with metastatic breast cancer. 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.
Source: American Pharmaceutical Partners, Inc. and American Bioscience, Inc.