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marker, enrichment strategies should allow for collecting some data in the marker-negative population, FDA says in draft guidance.
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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.
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.
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.