Abraxane™ Commercially Available for Metastatic Breast Cancer Patients

Abraxane™ Commercially Available for Metastatic Breast Cancer Patients

American Pharmaceutical Partners, Inc. has announced that Abraxane (paclitaxel protein-bound particles for injectable suspension) has been launched and is available for patients with metastatic breast cancer.

Abraxane is a solvent-free nanoparticle including albumin that encapsulates Taxol. Taxol consists of the taxane in a Cremophor solvent, which itself is responsible for a significant portion of toxicities associated with the chemotherapy agent. Conversely, Abraxane takes advantage of properties of albumin in delivering the taxane, such as its natural transporting capabilities, its tolerability and its size. The 100- and 200-nm particles guide in selectively delivering the chemotherapy agent to tumor cells, as particles are too big for many normal cells that are naturally tightly adjoined. Cancer cells tend to be more loosely joined, allowing for the particles to enter. No premedications to prevent hypersensitivity reactions are required with Abraxane, which can be delivered over a 30 minute period at a 50% greater dose than Taxol.

Abraxane is currently indicated for the treatment of metastatic breast cancer that has failed combination chemotherapy, or breast cancer that has relapsed within 6 months of adjuvant chemotherapy. Therapy prior to Abraxane should have included an anthracycline, unless contraindicated.[1]

Results from previous trials, including a phase III randomized trial have demonstrated superiority of Abraxane compared to Taxol as single-agent therapy in the metastatic setting for the treatment of breast cancer.[2], [3] Abraxane provided improved response rates, time to cancer progression and overall survival compared to Taxol, as well as allowing a reduction in administration times and toxicities. Abraxane will be marketed by the sales force of Abraxis Oncology, a division of American Pharmaceutical Partners (APP). Full prescribing information is available at www.abraxane.com.

Below is contact information regarding the launch of Abraxane:

American Pharmaceutical Partners, Inc.

Nicole Williams 847-969-2700

PondellWilkinson, Inc.

Rob Whetstone or Robert Jaffe 310-279-5963

References:

[1]Abraxane Prescribing Information. Available at:http://www.abraxane.com/HCP/Prescribing_Information.htm. Accessed June 2005

[2]Desai N, et al. ABI-007 (ABRAXANE), a Nanoparticle Albumin-Bound (NAB) Paclitaxel demonstrates superior efficacy vs Taxol in MBC: A Phase III Trial. Proceedings from the 2003 San Antonio Breast Cancer Symposium. San Antonio TX. December. 2003; Abstract 44

[3]Perez, E. New antitubulin agents. Proceedings from the 22nd annual Miami Breast Cancer Conference. Miami FL. 2005.

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