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GI NEUMEGA HAS "MODEST" BENEFIT IN REDUCING CHEMOTHERAPY-INDUCED THROMBOCYTOPENIA -- FDA REVIEWER; LABEL SHOULD CAUTION ABOUT VOLUME EXPANSION

Executive Summary

Therapy with Genetics Institute's Neumega at the recommended dose sought by the company led to a 28% platelet transfusion avoidance rate compared to 7% for placebo, Center for Biologics Evaluation & Research reviewer Richard Steffen, MD, told FDA's Biological Response Modifiers Advisory Committee July 24.

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