Home > Press > ABRAXANE Approved for Advanced Breast Cancer Patient Treatment in Quebec
Abstract:
Offers New Treatment Option for Metastatic Breast Cancer Patients
ABRAXANE Approved for Advanced Breast Cancer Patient Treatment in Quebec
Los Angeles, CA & Toronto, Canada | Posted on June 29th, 2009
Abraxis BioScience, Inc. (NASDAQ:ABII), an integrated biotechnology company, today announced the listing of ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) 100 mg in Quebec for the treatment of metastatic breast cancer with a recommendation from the Quebec Conseil du Médicament and approval from the Quebec Ministry of Health. ABRAXANE is approved and commercially available in Canada for the treatment of metastatic breast cancer, including first-line disease. The listing of ABRAXANE in Quebec offers an important new treatment option to Quebec women with advanced breast cancer.
"Based on clinical study results to date and my first-hand experience, I believe that ABRAXANE represents a very important and needed new treatment option for breast cancer," said Dr. André Robidoux, Director of the Breast Cancer Research Group of the CHUM Research Center. "ABRAXANE is the only taxane that is solvent free and is approved to treat metastatic breast cancer."
The Conseil's approval was based upon comparative clinical trials demonstrating the tumor response rate of ABRAXANE was nearly double for patients who received ABRAXANE compared to those who received solvent-based paclitaxel. Patients treated with ABRAXANE experienced a significant improvement in progression-free survival and prolonged time to tumor progression compared to patients treated with solvent-based paclitaxel.i Additionally, a recently published Phase II study demonstrated that ABRAXANE (administered weekly at 150 mg/m2) nearly doubled progression-free survival over docetaxel injection (14.6 months versus 7.8 months respectively p=0.012).ii ABRAXANE is indicated in Canada at a dose of 260 mg/m2 every three weeks for the treatment of metastatic breast cancer.
ABRAXANE uses the natural properties of a human protein, albumin, to deliver the drug more effectively to tumors. By wrapping the albumin around the active drug, ABRAXANE can be administered to patients at higher doses without the use of toxic solvents - often the cause of significant treatment-related side effects with other taxane chemotherapies. Unlike most taxane chemotherapies, ABRAXANE eliminates the patient's need for premedication during treatment to avoid allergic reactions caused by solvents . Additionally, patients can receive treatment in as little at 30 minutes compared to more than three hours needed for solvent-based paclitaxel.
"With this approval, Quebec doctors and patients now have another effective treatment option to help women in their fight against advanced breast cancer," said Lyndal Walker, Vice President and Managing Director, Abraxis BioScience Canada.
According to Canadian Cancer Society statistics, an estimated 5,900 Quebec women were diagnosed with breast cancer in 2008.iii With an average of 437 women diagnosed with breast cancer every week, breast cancer is the second leading cause of cancer mortality among Canadian women.iv
ABRAXANE has now been approved in 36 countries across Europe, North America, Asia and Australia. Abraxis is continuing to expand its clinical experience with ABRAXANE and its potential in treating a variety of tumor types at multiple stages of disease as a single agent and in combination.
i Gradishar WJ, Tjulandin S, Davidson N, et al. Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. J. Clin Oncol. 2005;23(31):7794-803.
ii Gradishar et al. Significantly Longer Progression-Free Survival With nab-Paclitaxel Compared With Docetaxel As First-Line Therapy for Metastatic Breast Cancer. J Clin Oncol. 2009; 0: JCO.2008.18.5397v1.
iii Canadian Cancer Society. Breast cancer: the facts. October 2008.
Available at: www.cancer.ca/quebec/about%20us/media%20centre/~/media/CCS/Quebec/Qui_sommes_nous/Salle_des_nouvelles/Feuilles_de_faits/Cancer_du_sein_Faits2008_QC-ang.ashx
iv Canadian Cancer Society. Breast Cancer Stats. 16 April 2009. Available at www.cancer.ca/canada-wide/about%20cancer/cancer%20statistics/stats%20at%20a%20glance/breast%20cancer.aspx?sc_lang=.
####
About Abraxis BioScience, Inc.
Abraxis BioScience is a fully integrated global biotechnology company dedicated to the discovery, development and delivery of next-generation therapeutics and core technologies that offer patients safer and more effective treatments for cancer and other critical illnesses. The company's portfolio includes the world's first and only protein-bound nanoparticle chemotherapeutic compound (ABRAXANE®), which is based on the company's proprietary tumor targeting technology known as the nab® platform. The first FDA approved product to use this nab platform, ABRAXANE, was launched in 2005 for the treatment of metastatic breast cancer and is now approved in 36 countries. The company continues to expand the nab platform through a robust clinical program and deep product pipeline. Abraxis trades on the NASDAQ Global Market under the symbol ABII.
About ABRAXANE®
ABRAXANE is a solvent-free chemotherapy treatment option for metastatic breast cancer which was developed using Abraxis BioScience's proprietary nab® technology platform. This protein-bound chemotherapy agent combines paclitaxel with albumin, a naturally-occurring human protein. By wrapping the albumin around the active drug, ABRAXANE can be administered to patients at higher doses, delivering higher concentrations of paclitaxel to the tumor site than solvent-based paclitaxel. 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, pancreatic, gastric and head and neck.
In June 2006 ABRAXANE was approved by Therapeutic Products Directorate of Health Canada under a Notice of Compliance for the treatment of metastatic breast cancer in Canada. The U.S. Food and Drug Administration approved ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) 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
For more information, please click here
Contacts:
Abraxis BioScience, Inc.
Maili Bergman
310-883-1300
or
Investors and Media Inquiries
High Road Communications
Carrie Baker
416-644-2264
Copyright © Abraxis BioScience, Inc.
If you have a comment, please
Contact us.
Issuers of news releases, not 7th Wave, Inc. or Nanotechnology Now, are solely responsible for the accuracy of the content.
Bookmark:
News and information
Pioneering breakthrough of chemical nanoengineering to design drugs controlled by light June 18th, 2013
Study Shows How the Nanog Protein Promotes Growth of Head and Neck Cancer June 18th, 2013
New Method to Synthesize Zinc Oxide Nanoparticles with High Catalytic Activity June 18th, 2013
Production of Polyaniline Biosensors Modified with Conductive Polymer Composites June 18th, 2013
Nanomedicine
Pioneering breakthrough of chemical nanoengineering to design drugs controlled by light June 18th, 2013
Study Shows How the Nanog Protein Promotes Growth of Head and Neck Cancer June 18th, 2013
Production of Polyaniline Biosensors Modified with Conductive Polymer Composites June 18th, 2013
European Technology Platform for Nanomedicine and Nanomed2020 European Consortium Launch the Nanomedicine Award June 17th, 2013
Announcements
Pioneering breakthrough of chemical nanoengineering to design drugs controlled by light June 18th, 2013
Study Shows How the Nanog Protein Promotes Growth of Head and Neck Cancer June 18th, 2013
New Method to Synthesize Zinc Oxide Nanoparticles with High Catalytic Activity June 18th, 2013
Production of Polyaniline Biosensors Modified with Conductive Polymer Composites June 18th, 2013
Nanobiotechnology
Iranian Scientists Produce Dynamometer for Nanoparticles, Biocells June 15th, 2013
Shape of nanoparticles points the way toward more targeted drugs: A collaboration of scientists at Sanford-Burnham and the University of California, Santa Barbara, finds that rod-shaped particles, rather than spherical particles, appear more effective at adhering to cells June 10th, 2013
Catching individual molecules in a million with optical antennas inside nano-boxes June 10th, 2013
Whispering light hears liquids talk: University of Illinois researchers build first-ever bridge between optomechanics and microfluidics June 7th, 2013