LAUSR

Much has been written and discussed related to the recent plethora of drug approvals by the United States Food and Drug Administration (FDA) for acute myeloid leukemia (AML). This topic has been met with appropriate enthusiasm for the following reasons: (a) AML is among the most difficult cancers to treat, with very poor historical outcomes; (b) Efforts to develop therapies for AML have been heroic, with more clinical trial activity for this disease than many more common malignancies; and (c) Until recently, these efforts were largely unsuccessful. It is now appropriate to reflect on the present and future landscape for drug development in AML, and to contrast it with the earlier fallow period, in order to determine what lessons may be learned and obstacles avoided. It is my belief that the development and FDA approval of venetoclax represents a paradigm shift in how AML is and will be treated, and this editorial is built on the premise that venetoclax is practicechanging in AML. Those who disagree with this conclusion will find fault with many observations and suggestions herein. Despite this, it is my position that we are in a new “post-venetoclax” era, which necessitates the following changes in drug development strategies to ensure continued successes.