FDA Approves New Breast Cancer Drug.
Abraxane Boosts Effectiveness of Breast Cancer Chemotherapy
Jan. 10, 2005 -- The FDA has approved the first in a new class of drugs that reduces the side effects and boosts the effectiveness of traditional breast cancer chemotherapy.
The drug, Abraxane, is part of a class of drugs known as "protein-bound particle" drugs, which represent a new way of delivering chemotherapy drugs to cancer patients.
By binding the active ingredient (the breast cancer drug Taxol) to microscopic protein molecules, these drugs eliminate the need for using toxic solvents to deliver the drugs into the bloodstream, and reduce potentially harmful side effects.
Because they contain no toxic solvents, researchers say protein-bound drugs enable doctors to use up to 50% higher doses of chemotherapy without compromising patient safety. This form of drugs also requires no premedication to prevent hypersensitivity reactions and can be given over a 30-minute period using standard intravenous tubing.
The FDA has approved the first of these drugs, Abraxane, for the treatment of breast cancer after failure of combination chemotherapy for disease that has spread beyond the breast, or breast cancer relapses within six months of chemotherapy treatment.
Clinical trials of Abraxane showed that it produced nearly double the response rate compared with solvent-based Taxol chemotherapy in a group of 460 women with advanced breast cancer.