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FDA approve new breast cancer drug

United Press International

Monday, January 10, 2005


WASHINGTON, Jan 08, 2005 (United Press International via COMTEX) -- The Food and Drug Administration has approved an injectable breast cancer treatment made by two U.S. pharmaceutical companies.

Abraxane, made by American Pharmaceutical Partners and American Bioscience is "indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy," a spokesman for the companies said.

Prior therapy should have included an anthracycline, "unless clinically contraindicated."

The FDA's approval marks a new class of "protein-bound particle" drugs for breast cancer patients, the companies said.

Abraxan is made of albumin-bound paclitaxel nanoparticles and is free of toxic solvents.

It has 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, the companies said.



Copyright 2005 by United Press International.

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ing or not. Thought I would pass it along. K