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Rob,
I am just new to the Yahoogroups - CML site, but I
already want to say a GREAT BIG, THANK YOU for
the great job that you are doing. And the
same to all the contributors...I am extremely pleased with the
assistance that all of you have been
providing. Your personal stories just great...keeeeeep up the great
work.
Sincerely,
Jim Beck
dx 8/2001
age 63
600mg IM
----- Original Message -----
Sent: Thursday, January 27, 2005 12:54
PM
Subject: [CML] U.S. Food and Drug
Administration Drug Approval Summary: Conversion of Imatinib Mesylate (STI571;
Gleevec) Tablets from Accelerated Approval to Full Approval
Imatinib mesylate (Gleevec, Novartis Pharmaceuticals East Manruer, NJ)
received accelerated approval on May 10, 2001 for the treatment of patients
with chronic myeloid leukemia (CML) in (a) chronic phase after failure of
IFN-alpha therapy, (b) accelerated phase, and (c) blast crisis. The
accelerated approval was accompanied by a postmarketing commitment by Novartis
Pharmaceuticals to continue patient follow-up to determine duration of
treatment response and survival. The present review, based on a safety and
efficacy report submitted on December 20, 2002, summarizes data applicable to
the conversion of these three CML indications to full approval status
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- Re: [CML] U.S. Food and Drug Administration Drug Approval Summa... James Beck
-