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Learning From Pixuvri: Pazdur Urges Sponsors To Test Cancer Drugs In Earlier Stages

Executive Summary

The Oncologic Drugs Advisory Committee's review of Cell Therapeutics' Pixuvri (pixantrone) - where the treatment for relapsed/refractory non-Hodgkins lymphoma was roundly rejected - was another opportunity for FDA Office of Oncology Drug Products Director Richard Pazdur to urge sponsors to look beyond late-stage settings to test cancer drugs

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

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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