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Document Preview Bexxar Receives Strong Support from FDA Advisory Panel |
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Title: |
Bexxar Receives Strong Support from FDA Advisory Panel |
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2002 |
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$34 |
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#289073 |
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FOR IMMEDIATE RELEASE
| For more information: | ||||
| Jim DeNike Corixa Corporation 206-754-5716 denike@corixa.com |
Jill Dolgin GlaxoSmithKline 919-483-2839 jill.g.dolgin@gsk.com |
Mike Beyer Sam Brown Inc. 312-961-2502 |
BEXXAR RECEIVES STRONG SUPPORT FROM FDA ADVISORY PANEL
ODAC Panel Agrees that BEXXAR Studies Show Clinical Benefit in
Chemotherapy- and Rituximab-Refractory Low-grade,
Transformed Low-grade NHL
SEATTLE and PHILADELPHIA, December 17, 2002 Corixa Corporation (Nasdaq: CRXA) and GlaxoSmithKline (NYSE: GSK) today announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) agreed that studies of the investigational radioimmunotherapy BEXXAR (tositumomab and iodine I 131 tositumomab) provided substantial evidence of clinical benefit in both rituximab-refractory patients and in chemotherapy-refractory, low-grade and follicular non-Hodgkins lymphoma (NHL), with or without transformation. The panel voted 10-3 in support of the efficacy of BEXXAR therapy in rituximab-refractory patients and unanimously supported its clinical utility in chemotherapy-relapsed and refractory, low-grade NHL, with or without transformation. BEXXAR therapy is being co-developed in the United States by Corixa and GlaxoSmithKline.
The FDA is not bound by the Committees action, but often takes its recommendations into consideration when determining marketing approval of a new product. The new Prescription Drug User Fee Act (PDUFA) goal date for the FDA to complete its review of all materials regarding BEXXAR therapy is May 2, 2003.
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