Immunotherapy

FDA accepts sBLA for expanded use of BEXXAR; decision expected by January 2005

Published in Medical Letter on the CDC and FDA, October 24th, 2004

Corixa Corp. (CRXA), a developer of immunotherapeutics, and GlaxoSmithKline (GSK) announced that the U.S. Food and Drug Administration (FDA) has accepted Corixa's supplemental biologics license application (sBLA) for expanded use of the BEXXAR therapeutic regimen.

The FDA also has granted priority review status to the BEXXAR BLA. As a result, the companies expect the FDA to complete its review of the BEXXAR sBLA by January 2005.

Corixa has requested accelerated approval for the expanded use of BEXXAR in treatment of patients with relapsed or refractory low-grade, follicular or transformed CD20-positive non-Hodgkin lymphoma (NHL) whose disease has...

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Source: Medical Letter on the CDC and FDA (2004-10-24)

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