Untargeting Xalkori? Hints Of Efficacy In ALK-Negative Patients Must Be Addressed, FDA Says
This article was originally published in Pharmaceutical Approvals Monthly
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.