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Biotech / Medical : VD's Model Portfolio & Discussion Thread
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To: Vector1 who wrote (9533)2/3/2003 9:49:51 PM
From: Miljenko Zuanic  Read Replies (1) of 9719
 
<<What are your views on the incidence of nueropathy. Do you think it is caused by Velcade or a remnant of prior chemo regimes.>>

From two PII trials it is clear that Velcade do cause neuropathy. The question is was this reversible and how severe? 7% dropped out because of the intolerable neuropathy, in part due to preexisting condition (preexisting neuropathy). Unfortunately, true tox profile will be known only after PIII, where reduction of the dose, due to neuropathy, is in protocol. Somehow, severe neuropathy is not, yet, issue for other indications, but does not means that will not surface.

For third line MM neuropathy will not hurt approval, imo, but will limit off label for now.

Miljenko
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