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Industry, Cancer Groups Draft Blueprint For PD-1 Companion Dx Approvals

This article was originally published in The Gray Sheet

Executive Summary

Drug and test firms want to standardize FDA's companion diagnostic assessments for the high-profile new class of PD-1/PD-LI immunotherapy cancer drugs. A draft blueprint for addressing the issue was discussed at a March 24 meeting convened by FDA and several cancer research organizations.

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