On The Trail Of Specifics: Industry Critiques Draft Enrichment Guidance
When and how to incorporate marker-negative patients into enriched clinical trials remains undefined for drug companies, which appear accepting of limited indications for marker-positive patients.
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Despite Bob Temple’s assurance that draft enrichment guidance allows companies to exclude biomarker-negative patients, industry asks FDA for more guidance on when they can safely say a biomarker is discriminatory.
Without clear-cut evidence that a drug will not work in patients without a predictive marker, enrichment strategies should allow for collecting some data in the marker-negative population, FDA says in draft guidance.
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.