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Crizotinib Holds Promise For Lung Cancer, And For Pfizer Oncology

Executive Summary

CHICAGO - Pfizer's promising targeted lung cancer candidate - the ALK inhibitor crizotinib - exemplifies the dream of all oncology sponsors. The company had a home-grown agent already in the clinic when new research suggested a potential genetic marker and, after some readjustment, Pfizer has evidence of activity in a molecularly identified subset of patients in short order

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

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.

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

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.

Pfizer’s Crizotinib Eases Past FDA With Targeted Population

FDA is showing for the second time in as many weeks that all things are possible when it comes to clearing targeted oncologics with compelling evidence. The agency cleared Pfizer’s Xalkori (crizotinib) for late-stage non-small cell lung cancer Aug. 26, just under five months from submission and based on early stage evidence.

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