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Old 01-08-2005, 12:23 AM   #1
Merridith
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SCHAUMBURG, Ill., January 07, 2005 /PRNewswire-FirstCall
American Pharmaceutical Partners, Inc. (Nasdaq: APPX), and American Bioscience, Inc. (ABI) announced today that the U.S. Food and Drug Administration (FDA) has approved ABRAXANETM for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in metastatic breast cancer. ABRAXANETM is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.

The approval marks a new class of "protein-bound particle" drugs, now made possible by ABI's proprietary nanoparticle albumin-bound (nabTM) technology. ABRAXANETM is the first in this new class of drugs.

ABRAXANETM, consisting only of albumin-bound paclitaxel nanoparticles, is free of toxic solvents and demonstrated a superior response rate with an almost doubling of the reconciled target lesion response rate when compared with the solvent-based Taxol® in a prospectively randomized trial of 460 patients with metastatic breast cancer. Because it contains no toxic solvents, this next-generation taxane product enables the administration of 50% more chemotherapy with a well-tolerated safety profile, requires no premedication to prevent hypersensitivity reactions and can be given over 30 minutes using standard IV tubing.

"ABRAXANETM provides a much-needed new treatment option for women with metastatic breast cancer," said principal clinical trial investigator William J. Gradishar, M.D., Associate Professor of Medicine, Division of Hematology and Medical Oncology and Co-Director, Lynn Sage Breast Cancer Program at Northwestern Memorial Hospital. "The pivotal clinical trial results demonstrated that ABRAXANETM had superior response rate when compared to Taxol® in patients with metastatic breast cancer. For the first time we are able to offer patients the full therapeutic benefits of paclitaxel. This makes ABRAXANETM a significant advance in the way we treat breast cancer."

"ABRAXANETM has an improved therapeutic index compared to Taxol® in the treatment of metastatic breast cancer based on its superior response rate and well tolerated safety profile," said Joyce A. O'Shaughnessy, M.D., co-director, Breast Cancer Research, and Director, Breast Cancer Prevention, at Baylor-Charles A. Sammons Cancer Center in Dallas, TX. "Patients receiving Cremophor-based taxanes unfortunately are exposed to toxicities caused by the solvent rather than the active chemotherapy drug. The patients with metastatic breast cancer who were treated with ABRAXANETM not only achieved the superior response rate, but they also benefited from the fact that ABRAXANETM does not use toxic solvents to deliver the active drug."

"ABRAXANETM is an important therapeutic breakthrough since it is an active new class of drugs that addresses the toxicities associated with solvents in taxane-based chemotherapy, namely hypersensitivity reactions, severe myelosuppression, prolonged peripheral neuropathy and severe edema," said Edith Perez, M.D., Professor of Medicine, Mayo Clinic College of Medicine, Chair Breast Committee, North Central Cancer Treatment Group. "Grade 4 neutropenia occurred in less than 10% of the patients. In the patients who developed Grade 3 peripheral neuropathy, rapid improvement occurred after a median of only 22 days. It is significant that ABRAXANETM can be safely administered to both young and elderly patients. Plans currently are underway to study this next-generation taxane in combination with other chemotherapeutic agents in the treatment of front-line metastatic breast cancer."

"The designation of a new protein particle drug class and the approval of ABRAXANETM mark the culmination of over a decade of research in the science of albumin-bound nanoparticles by the ABI team," said Patrick Soon-Shiong, M.D., Executive Chairman of American Pharmaceutical Partners and Chairman, President and Chief Executive Officer of American Bioscience. "We are gratified that our efforts will now benefit breast cancer patients and are excited about the future impact that the nab technology platform may have on the way we treat cancer and other diseases."

"We are pleased to offer women with metastatic breast cancer a new, innovative treatment option, and this approval is a defining moment for APP. We applaud the tireless efforts of the ABRAXANETM team at ABI and APP, the clinical investigators, and the patient participants in the trial who helped bring ABRAXANETM to market and make it available to treat women who are often faced with few options when they are diagnosed with advanced breast cancer," said Al Heller, President and Chief Executive Officer of American Pharmaceutical Partners

Read the rest of this article at: http://www.appdrugs.com/010705PR.html
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