Enriched Trials Not Just About Marker-Positive Patients, FDA Says
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marker, enrichment strategies should allow for collecting some data in the marker-negative population, FDA says in draft guidance.
You may also be interested in...
Will Portola’s Betrixaban Data Pass Muster With FDA?
Portola says that it does not expect it will need to do a second Phase III study to get FDA approval for betrixaban, after missing major endpoint in APEX, but analysts have doubts.
Two Approaches To PD-1 Blocker Pediatric Studies Could Help Clarify Biomarker’s Role
Merck plans to enrich its Phase II study for MK-3475 with patients whose tumors express PD-L1; Bristol would take all comers in its Phase I/II trial of nivolumab.
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.