FDA to Consider Abraxis Request

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A Food and Drug Administration advisory committee on Thursday will consider a request by Abraxis BioScience Inc. to be allowed to market its Abraxane drug for wider use in breast cancer patients.


If the request is granted, the company could market the drug without submitting additional test results.


An announcement of the committee’s consideration did not state when a decision could be expected.


Los Angeles-based Abraxis received FDA approval last year to sell Abraxane for limited treatment of advanced breast cancer patients who had not benefited from established chemotherapy regimes. An FDA endorsement for expanded use would help the company meet Wall Street expectations. Abraxane had $134 million in sales last year, but sales so far this year have not grown fast enough to satisfy analysts.


Abraxane is an injectable form of the chemotherapy drug paclitaxel, which fights cancer growth. Bristol-Myers Squibb Co.’s Taxol use the same ingredient, but Abraxis’ scientists combined paclitaxel with a protein that makes it easier for the body to absorb.


Abraxis is basing its request for wider use of Abraxane on already available Taxol studies.

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