ABRAXANE Approved For Advanced Breast Cancer Patient Treatment In Quebec

Main Category: Breast Cancer
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 01 Jul 2009 - 3:00 PDT

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Abraxis BioScience, Inc. (NASDAQ:ABII), an integrated biotechnology company, 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.

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.

References

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 here.

iv Canadian Cancer Society. Breast Cancer Stats. 16 April 2009. Available here.

Source
Abraxis BioScience, Inc.