Crizotinib Holds Promise For Lung Cancer, And For Pfizer Oncology
Executive SummaryCHICAGO - 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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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.
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.