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Biotech / Medical : momo-T/FIF
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To: Icebrg who wrote (3069)9/14/2005 3:42:55 PM
From: Icebrg  Read Replies (1) of 12215
 
It is not only the MLNM board that is toxic. The same seems to be the case for Revlimid. 80 % of the patients experienced grade 3 or 4 adverse events with the dose used. From Celgene's PR today:

These questions were voted upon by the committee:

Question #1: Randomized controlled trials allowed for direct comparisons of treatment effects and safety between treatment arms. A single arm study has been submitted using an 8-week run-in period to serve as a baseline for each patient's transfusion requirements. A comparison is subsequently made to a follow-up 8-week period on REVLIMID to compare transfusion requirements. Does this study design allow adequate characterization of REVLIMID's treatment effect in the population described in the proposed indication? Vote 11 Yes - 4 No

Question #2: In this single arm trial, 80% of patients enrolled in MDS- 003 has dose reductions and/or delays and 80% of patients experienced either grade 3 or 4 adverse events. Data do not exist on the efficacy and safety of lower REVLIMID doses. Approval of a drug is contingent upon being able to write adequate product labeling, requiring a recommended dose and characterization of a safety profile. Do the data provided in this single-arm trial provide a basis for a recommendation dose and adequate description of a safety profile? Vote 2 Yes -13 No

Question #3: Please characterize the magnitude of the benefit and risk of REVLIMID® in the indication being sought. After this characterization, does this risk/benefit analysis warrant approval? Vote 10 Yes -5 No
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