- March 01, 2012
- Taiho Pharmaceutical Co., Ltd.
ABRAXANE® I.V. Infusion 100mg Application
Submitted for Approval of Additional Indications in Japan
Taiho Pharmaceutical Co., Ltd. (HQ: Tokyo, President: Toru Usami, hereafter Taiho) announced today that it has filed an application to the Japanese Ministry of Health, Labour and Welfare for the approval of additional indications of ABRAXANE® I.V. Infusion 100 mg, an antineoplastic for injectable suspension (paclitaxel protein-bound particles for injectable suspension, albumin-bound, launched on September 24, 2010). This application consists of additional indications for gastric cancer and non-small cell lung cancer.
ABRAXANE was approved for the treatment of breast cancer in July 2010 in Japan. With its innovative, patented nanotechnology platform - nab technology, ABRAXANE leverages the natural transport properties of albumin to deliver more cytotoxic drug to the tumor. ABRAXANE features improved efficacy and safety for breast cancer treatment as well as easier administration compared to solvent-based paclitaxel.
Taiho is confident that ABRAXANE will continue to offer better treatment options for cancer patients and medical professionals, and will sustain its development in the oncology field.
ABRAXANE is a solvent-free chemotherapy treatment option for metastatic breast cancer which was developed using Celgene's proprietary nab technology platform. This protein-bound chemotherapy agent combines paclitaxel with albumin, a naturally-occurring human protein. Its technology eliminates the need for steroids and other pre-medication for preventing hypersensitivity reactions, which is required for solvent-based paclitaxel. In addition, ABRAXANE shortens the infusion period, thereby relieving the burden on patients and potentially improving the efficiency of outpatient chemotherapy.
The U.S. Food and Drug Administration approved ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) in January 2005 for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. ABRAXANE is currently in various stages of investigation for the treatment of the following cancers: expanded applications for metastatic breast, non-small cell lung, malignant melanoma and pancreatic. ABRAXANE was originally developed by Abraxis BioScience, a wholly-owned subsidiary of Celgene Corporation.
Information in this news release was current as of the original release date.