Abraxis BioScience, Inc. (Abraxis) (NASDAQ:ABII), an integrated biotechnology company, today announced that the European Commission has granted marketing approval for ABRAXANE(R) powder for suspension for infusion (an albumin-bound nanoparticle formulation of paclitaxel) for the treatment of metastatic breast cancer in patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline-containing therapy is not indicated. The Phase III clinical trial results on which this approval was based demonstrated that ABRAXANE doubled the response rate and significantly prolonged progression-free survival and overall survival versus Taxol(R) in the approved indication.
"ABRAXANE provides a much-needed new treatment option for women with metastatic breast cancer in Europe," said principal clinical trial investigator William J. Gradishar, M.D., Professor of Medicine, Northwestern University, Feinberg School of Medicine, and Division of Hematology and Medical Oncology and Co-Director, Lynn Sage Breast Cancer Program at Northwestern Memorial Hospital. "Given the superior patient outcomes demonstrated in two Phase III clinical trials, ABRAXANE has become the taxane therapy of choice for oncologists in the US in this setting."
ABRAXANE is now approved in 33 countries including the U.S. and Canada. In Europe, there are approximately 300,000 cases of metastatic breast cancer. The product is currently under active review in Australia, Russia, Korea and China by their respective regulatory agencies.
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