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Review Challenge: Deduce Efficacy From One Subset Of One Single-Arm Trial

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Genmab and GlaxoSmithKline provided FDA with data from two trials to support the efficacy of Arzerra in refractory chronic lymphocytic leukemia, but the agency only considered a subset of one of the studies to count for proof of efficacy

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