Oncology Endpoint Guidance: US FDA Reaffirms Support For EFS, MRD In Update
Update of 2007 guidance includes discussion on use of newer endpoints and clarifies that oncology endpoints can serve different purposes.
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ctDNA Can Be Used For Patient Selection and Enrichment, But Not As Early Efficacy Endpoint, US FDA Says
More data are required to establish circulating tumor DNA, a blood biomarker, as reasonably likely to predict benefit on long-term outcomes in early-stage, solid tumor trials, agency says in new draft guidance.
Phase III study in newly diagnosed patients with NPM1-mutated AML could enable Kronos’ SYK-inhibitor to reach market two years earlier under accelerated approval than it would under a traditional endpoint, company says.
As new drugs move into earlier lines of therapy for use in combination and for longer periods, payers are growing more sensitive to myeloma therapies' costs in the US and major ex-US markets.