Again, with feeling: FDA urges PD-L1 standardization, patient stratification

FDA is cracking down on broad labels when predictive biomarkers exist — even when those biomarkers aren’t perfect. A meeting of FDA’s Oncologic Drugs Advisory Committee this week challenged the use of PD-1 inhibitors in patients with certain tumors expressing low levels of PD-L1, and took a step toward standardizing PD-L1 expression requirements for the class.

It’s the latest show of force supporting precision medicine by FDA, and a signal that companies need to be executing on thorough biomarker stratification strategies when biomarkers are available. ...