Cancer Trial Endpoints: Minimal Residual Disease Eyed As Surrogate
More work needs to be done to validate MRD as predictive of clinical outcomes in hematological malignancies before it can be used as the basis for accelerated approval, FDA and other stakeholders say.
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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.
Pathologic complete response eventually may be a surrogate endpoint for survival, but researchers and the US FDA outlined several problems that must be resolved first.
Amgen sees the approval as a platform to expand blinatumomab into other hematologic malignancies using similar approaches.