FDA approves Abraxane for metastatic breast cancer

American Pharmaceutical Partners, Inc. and American Bioscience, Inc. (ABI) announced that the U.S. Food and Drug Administration (FDA) has approved Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in metastatic breast cancer.

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.

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.

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