APP soars on breast cancer approval

Abraxane is indicated 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.

The approval marks a new class of protein-bound particle drugs, now made possible by American Bioscience’s proprietary nanoparticle albumin-bound (nab) technology. Abraxane is the first in this new class of drugs.

Abraxane, 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 Bristol-Myers Squibb’s 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.