Kronos Bio said Thursday that it had reached an agreement with the Food and Drug Administration for a unique, late-stage clinical trial that will accelerate the development — and potentially the approval — of its drug for patients with a genetically defined type of leukemia.
To demonstrate the efficacy of the drug, called entospletinib, Kronos will use highly sensitive sequencing tests to confirm undetectable levels of leukemic cells in patients. Achieving a negative finding for “measurable residual disease” is associated with longer remission and improved survival.
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