FDA Approves Abraxane for Metastatic Breast Cancer Treatment

The U.S. Food and Drug Administration has approved Abraxane, a new class of "protein-bound particle" drugs, for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Abraxane is the first in this new class of drugs, utilizing nanoparticle albumin-bound (nab) technology to provide a superior response rate and reduced toxicity compared to traditional solvent-based chemotherapy.

Key Takeaways:

• Abraxane is approved for the treatment of metastatic breast cancer after failure of combination chemotherapy or relapse within 6 months of adjuvant chemotherapy.
• The approval marks a new class of "protein-bound particle" drugs enabled by American Bioscience, Inc.'s proprietary nanoparticle albumin-bound (nab) technology.
• Abraxane demonstrated a superior response rate, with an almost-doubling of the reconciled target lesion response rate compared to solvent-based Taxol in a prospectively randomized trial of 460 patients with metastatic breast cancer.
• Abraxane is free of toxic solvents and can be administered with 50% more chemotherapy than traditional Taxol, with a well-tolerated safety profile.
• Abraxane does not require premedication to prevent hypersensitivity reactions and can be given over 30 minutes using standard IV tubing.
• The pivotal clinical trial results demonstrated a significant improvement in response rate, with Abraxane offering a superior treatment option for women with metastatic breast cancer.
• Abraxane has shown promise as a therapeutic breakthrough, addressing the toxicities associated with solvents in taxane-based chemotherapy, including hypersensitivity reactions, severe myelosuppression, and prolonged peripheral neuropathy.
• Plans are underway to study Abraxane in combination with other chemotherapeutic agents in the treatment of front-line metastatic breast cancer.

Statistics:

• 460 patients with metastatic breast cancer participated in the prospectively randomized trial comparing Abraxane to Taxol.
• Abraxane demonstrated a superior response rate, with an almost-doubling of the reconciled target lesion response rate compared to Taxol.
• Grade 4 neutropenia occurred in less than 10% of patients.
• Rapid improvement in Grade 3 peripheral neuropathy occurred after a median of only 22 days.
• Abraxane can be safely administered to both young and elderly patients.

Sources:

• American Pharmaceutical Partners, Inc. (APPX) press release
• U.S. Food and Drug Administration (FDA) approval announcement
• Health & Medicine Week article, Copyright 2005, Health & Medicine Week via NewsRx.com & NewsRx.net.