New form of Taxol approved.
Bristol-Myers Squibb's Taxol and Sanofi-Aventis' Taxotere have new competition with a new FDA approval. The new drug, Abraxane –which is manufactured by American Pharmaceutical Partners, was approved for women with advanced breast cancer who have not responded to chemotherapy Abraxane features an easier administration and avoids some side effects.
In its clinical trial involving 460 women, tumors shrank in 21.5 percent of those who got Abraxane compared with 11.1 percent of those who received Taxol. The company has not yet provided data on whether Abraxane extended the lives of those women.
The women getting Abraxane in the trial had fewer cases of severe neutropenia, a decrease in white blood cells that can leave a patient vulnerable to infections. Some side effects like nerve damage, severe pain in the muscles or joints, and vomiting were more common with Abraxane.
American Pharmaceutical Partners, based in Schaumburg, Ill., is a generic maker that, with Abraxane, is moving into branded drugs.