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Accelerated Approval Does Not Speed Oncologics To Market, Study Finds

This article was originally published in RPM Report

Executive Summary

Development time is the same for cancer drugs cleared under subpart H and under the regular approval pathway, according to a study in the Journal of Clinical Oncology. Article calls attention to idea that cancer drugs may need new, more favorable FDA policies on surrogate markers.

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Translating FDA for Investors: Seattle Genetics Shrugs Off Public Lambasting at ODAC

Actions speak louder than words. That, at least, is how Seattle Genetics urged investors to think about a tongue lashing the company received during an advisory committee review of the cancer agent Adcetris Seattle Genetics may be right on two levels: the practical outcome of the meeting was positive, and the FDA rhetoric may not have been as directly aimed at the sponsor as a warning to all oncology drug developers.

Accelerated Withdrawal in Action: The Avastin Hearing Process

The June hearing on the status of Genentech’s metastatic breast cancer indication for Avastin will focus on a long list of substantive disagreements about the data. But any sponsor interested in the future of the accelerated approval process should study the back-and-forth in the hearing process itself.

The Avastin Dilemma: Two Personalities and Two Points of View on Cost Effectiveness

Two of the key figures in the 2009 health reform debate, Zeke Emanuel and Billy Tauzin, each use Genentech's Avastin to demonstrate the importance of doing cost effectiveness right. But they look at the same drug from very different points of view. Their perspectives provide a good guide to what is at stake in the design of federal approach to comparative effectiveness research.

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