American Bioscience Gains FDA Approval For Abraxane
1/11/2005 Karen Pihl-Carey BioWorld Online (www.bioworld.com) Providing new hope for breast cancer patients, Abraxane soon will offer the antitumor benefits, without the toxic solvent side effects, of paclitaxel. The FDA approved the product developed by American Bioscience Inc., of Santa Monica, Calif. It will be manufactured and marketed through the company's 70 percent-owned subsidiary American Pharmaceutical Partners Inc. (APP), of Schaumburg, Ill. "What this means to the breast cancer patient and to the physician is they can now provide the full potential of this drug paclitaxel," said Patrick Soon-Shiong, chairman, president and CEO of privately held American Bioscience and executive chairman of APP. Abraxane is indicated to treat breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. With the approval, the FDA has designated a new group of protein-bound particle drugs in which Abraxane is the first in the class. The product consists of albumin-bound paclitaxel nanoparticles, which are one-hundredth the size of a single red blood cell. "What is exciting now about Abraxane is it is the first of a new class of drug products, and second, it is the first taxane that is free of solvent," Soon-Shiong told BioWorld Today. "As a result, it can be given without premedication and without a black box warning of severe hypersensitivity reactions. "It can be given at a 50 percent higher dose of chemotherapy," he said, "and the outcome is an almost doubling of the response rate when compared to Taxol." Another [...]