Context Is Key To Accelerated Approval In Oncology, Arzerra Review Shows
This article was originally published in Pharmaceutical Approvals Monthly
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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Out Of The Shadow Of REMS: FDA Review Documents Show Emerging Importance Of Post-Marketing Requirements
Although often overshadowed by the novelty of FDA’s sweeping authority in constructing Risk Evaluation and Mitigation Strategies, examination of agency review documents suggest that the FDA Amendments Act’s other safety innovation, granting FDA the ability to require (i.e., enforce) post-marketing studies, is increasingly important to the approval of NDAs with marginal data on issues of concern.