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FDA Accepts New Drug Application of Abraxane for the Treatment of Metastatic Breast Cancer
"I am very proud of the tremendous effort by the entire development team in accomplishing this successful filing of an electronic NDA. FDA's acceptance of this NDA filing moves us one step closer to providing a potential new treatment for metastatic breast cancer patients," said Patrick Soon-Shiong, M.D., Chairman, President and Chief Executive Officer of American Pharmaceutical Partners. "By meeting this important milestone our clinical development plan for ABRAXANE in breast cancer remains on track. With this acceptance we are now aggressively expanding our clinical development program to pursue indications in other malignancies such as non-small cell lung cancer and ovarian cancer, as well as combination therapies of ABRAXANE with other chemotherapeutic agents."
The filing of the NDA is based primarily upon the pivotal randomized controlled Phase III trial that compared the safety and efficacy of 260 mg/m2 of ABRAXANE to 175 mg/m2 of TAXOL(R) administered every three weeks in 460 patients with metastatic breast cancer. The Phase III trial demonstrated that ABRAXANE resulted in an almost doubling of the response rate and a prolongation of time to tumor progression in first and second line patients with metastatic breast cancer.
ABI and APP are strategic partners in the development, manufacture and marketing of ABRAXANE. ABI is responsible for the clinical development and registration of ABRAXANE. APP has licensed the exclusive North American manufacturing and marketing rights for ABRAXANE.
About Breast Cancer
According to the American Cancer Society (ACS), while early detection efforts have decreased mortality rates, in 2004 an estimated 215,990 women are expected to be diagnosed with breast cancer that had already spread. Breast cancer is still the leading overall cause of death in women between the ages of 20 and 59, with 40,110 deaths estimated in 2004. One of every three cancers diagnosed in the United States is breast cancer; excluding skin cancer, it's the most common cancer among women.
Source: American Pharmaceutical Partners, Inc. and American BioScience, Inc.