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Synchronized Regulation: Tandem Approvals Of Xalkori, Diagnostic Required Considerable Coordination

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Pfizer’s Xalkori may be a model for fast development of a targeted oncologic and companion diagnostic, but that model is likely to be more aspiration than reality for future drug/diagnostic combinations. Extensive co-operation was required to keep two sponsors and two review centers on the same page – an effort that reflected the drug’s highly promising efficacy in early studies and FDA’s confidence that confirmatory studies would back up an accelerated approval.

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