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Biotech / Medical : Corixa [CRXA] - cancer vaccines
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To: nigel bates who wrote (147)5/15/2002 7:25:37 PM
From: SemiBull  Read Replies (1) of 222
 
Corixa/Bexxar -2: 3rd Time In 3 Months FDA Questions Drug

SEATTLE -(Dow Jones)- Following a recent meeting with the Food and Drug Administration, Corixa Corp. (CRXA) said the agency continues to question the clinical benefit of the company's cancer drug, Bexxar.

The drug's path to marketing approval hasn't been easy. Wednesday's announcement is the third time in three months the FDA has raised concerns about Bexxar.

In early March, the FDA sent Corixa a complete review letter, requesting more data on the drug. This followed an earlier review letter in which the agency questioned the sufficient safety and net clinical benefit evidence of the cancer drug.

At the most recent meeting, Corixa and GlaxoSmithKline PLC (GSK), co -developer of Bexxar, voiced their belief that the drug merits approval for the treatment of relapsed, refractory non-Hodgkin's lymphoma patients based on the high level of durable responses observed across multiple clinical studies.

The companies sai this level of persistent, independently confirmed, disease- free survival wasn't shown in clinical trials of other products.

As a result, the companies believe Bexxar does address a medical need that can't be met through administration of previously-approved products in this patient population.

Before the meeting, Corixa amended its biological license application for Bexxar to meet issues raised by the FDA in its second review letter.
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