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Biotech / Medical : Corixa [CRXA] - cancer vaccines
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To: Andreas Helke who started this subject3/25/2002 5:46:44 PM
From: nigel bates   of 222
 
SEATTLE & PHILADELPHIA--(BW HealthWire)--March 25, 2002--Corixa Corporation (Nasdaq:CRXA - news) and GlaxoSmithKline (NYSE:GSK - news), today announced that Corixa has notified the U.S. Food and Drug Administration (FDA) that it intends to amend its Biological License Application (BLA) for BEXXAR® (tositumomab, iodine I-131 tositumomab), an investigational radioimmunotherapy for the treatment of low-grade or transformed low-grade non-Hodgkin's lymphoma.
The companies also announced that they have formally requested a meeting with the FDA to discuss the complete review letter and potential next steps regarding this application. A meeting is expected to occur within the next 45 days.
BEXXAR is being co-developed by Corixa and GlaxoSmithKline in the United States.
As previously announced, Corixa received a complete review letter regarding the BEXXAR BLA on March 12, 2002. In the letter, the FDA stated that it believed additional data would be required to approve BEXXAR and gave Corixa the options of amending its application, notifying the Agency of its intent to file an amendment, withdrawing the application, or requesting an opportunity for a hearing on whether there are grounds for denying approval of the application...
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