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Re: pcrutch post# 144029

Monday, 06/18/2012 3:57:01 PM

Monday, June 18, 2012 3:57:01 PM

Post# of 257262
pcrutch,

You and poorgradstudent might be right about it looking less likely that Carfilzomib will get the accelerated approval, and I am starting to agree.


<I think Onyx's intolerance to Velcade argument appears to be a wash given that subQ Velcade is approved and much more tolerable.>

However, you are a bit too optimistic about the sc Velcade side-effect profile as there are still significant side-effect issues. Below is data from the Velcade naive patients used to compare IV and sc Velcade in the inferiority trial.


""Grade 3 and above adverse events with differences greater than 5 percent between routes of administration were:

• Peripheral neuropathy, subcutaneous 6 percent, intravenous 16 percent
• Thrombocytopenia, subcutaneous 13 percent, intravenous 19 percent
• Neuralgia, subcutaneous 3 percent, intravenous 9 percent""


http://www.takeda.com/press/article_44980.html

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