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BioPharmaceutical Medical Device United States

Untargeting Xalkori? Hints Of Efficacy In ALK-Negative Patients Must Be Addressed, FDA Says

This article was originally published in Pharmaceutical Approvals Monthly

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Executive Summary

FDA approved Pfizer’s lung cancer drug for patients positive for the gene translocation – but review documents show that agency reviewers focused on the efficacy seen in the few ALK-negative patients in the pivotal trial, and want Pfizer to follow up on that signal post-marketing. Regulatory expectations for disproving effect in the non-selected population will be an important issue as more personalized medicines reach the agency.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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