The U.S. Food and Drug Administration (FDA) has approved AbraxaneTM 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 proprietary nanoparticle albumin-bound (nabTM) technology developed by American Bioscience. 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 TaxolŽ 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.
"ABRAXANE provides a much-needed new treatment option for women with metastatic breast cancer," said principal clinical trial investigator William J. Gradishar, M.D., Associate Professor of Medicine, Division of Hematology and Medical Oncology and Co-Director, Lynn Sage Breast Cancer Program at Northwestern Memorial Hospital.
"The pivotal clinical trial results demonstrated that ABRAXANE had superior response rate when compared to Taxol in patients with metastatic breast cancer. For the first time we are able to offer patients the full therapeutic benefits of paclitaxel. This makes ABRAXANE a significant advance in the way we treat breast cancer."
SOURCE:
HealthSTAR Communications (http://www.healthstarpr.com)
