FDA committee recommends safety, efficacy test of Abraxis' Abraxane

By Angela McDaniels

Seattle, Sept. 7 - Abraxis BioScience, Inc. said the Oncologic Drugs Advisory Committee of the Food and Drug Administration recommended that the company and the FDA work together to identify selected patient populations for a "reasonably sized," randomized trial to confirm the safety and efficacy of Abraxane (paclitaxel protein-bound particles for injectable suspension) for use in the adjuvant treatment of node-positive breast cancer.

The FDA generally follows the advice of the committee, but it is not bound by the committee's recommendations.

"If the FDA agrees with [the] recommendation by the committee, this may enable approval in this indication earlier than typically expected," Michael J. Hawkins, the Los Angeles-based biopharmaceutical company's chief medical officer, said in a company news release.

Abraxane is approved in the United States for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy.

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