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Context Is Key To Accelerated Approval In Oncology, Arzerra Review Shows

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

By targeting a population with an unmet medical need that would qualify for review under FDA's accelerated approval regulations, GlaxoSmithKline and Genmab transcended a "suboptimal" development program and "uncertainty" regarding the magnitude of treatment effect to bring their anti-CD20 monoclonal antibody Arzerra (ofatumumab) to market, FDA review documents show

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